Disciplinary Action against Dr. Robert Bruce Allen


The Medical Practitioners Board of Victoria has concluded that Dr. Robert Bruce Allen engaged in serious unprofessional misconduct by failing to adequately manage the treatment of a patient with coronary artery disease who died in 1999. The patient was resistant to standard medical care, but the Board concluded that Allen had \failed to adequately communicate the importance of taking aspirin and cholesterol-lowering drugs and had failed to document any such communication in his records. The Board ordered Allen to undergo counseling in the appropriate treatment of patients with coronary artery disease.


MEDICAL PRACTITIONERS BOARD OF VICTORIA

Re: Dr Robert Bruce Allen [2005] MPBV 7

Reasons for Decision

Before:

Mr W F Johnson (Chair)
Dr Q De Zylva
Ms K A Sanders
Ms A Dea

Appearances:

 

Assisting the Panel:

Ms M Young of Counsel instructed by Minter Ellison, Lawyers

For the Practitioner:

Mr D Martin of Counsel instructed by John W Ball & Sons, Solicitors

Dates of Hearing:

28 February, 1 March and 3 May 2005

Date of Decision:

3 May 2005

Findings:

Dr Allen engaged in unprofessional conduct under paragraphs 3(1)(a) and (b) of the definition of “unprofessional conduct” in the Medical Practice Act 1994 and that conduct is of a serious nature under section 45A(1)(a) of the Act.

Determinations:

Pursuant to section 45A(2)(a) of the Act, Dr Allen is to undergo counselling, that counselling to be provided by a senior medical practitioner approved by the Deputy CEO of the Board and to involve at least three sessions to be completed within a period of six months. The counselling is to be paid for by Dr Allen and is to include the areas set out in paragraph 112 of these Reasons.

Pursuant to section 45A(2)(c) of the Act, Dr Allen is reprimanded for his failure to adequately manage the conventional cardiac treatment of Mr LM. 2

Reasons for Decision

[1] The Medical Practitioners Board of Victoria (“the Board”) determined under section 46 of the Medical Practice Act 1994 (“the Act”) that a Formal Hearing be held into the professional conduct of Dr Robert Bruce Allen. A Panel was convened and the hearing was held on 28 February, 1 March and 3 May 2005.

[2] The allegations heard by the Panel were contained in an Amended Notice of Formal Hearing (“Notice”). The Panel was required to determine whether Dr Allen:

1. engaged in unprofessional conduct within the meaning of paragraphs 3(1)(a) and/or (b) of the definition of "unprofessional conduct" in the Act in that, between on or about 21 July 1997 and on or about 22 August 1999, [he]:

(a) failed to adequately manage [Mr LM’s] coronary artery disease by failing to prescribe and/or recommend conventional cardiac medications and/or complete an assessment or review of his cardiac condition when [Dr Allen] knew or ought to have known of [Mr LM's] cardiac risk factors, family history of cardiac disease, cardiac investigation findings and his continued elevated cholesterol level;

(b) failed to adequately advise [Mr LM] before commencing chelation treatment that chelation therapy was of unproven benefit to patients with coronary artery disease and was only experimental; and

(c) failed to adequately document [his] clinical findings and management of [Mr LM] in [his] clinical notes including by failing to:

(i) obtain a report and/or clinical notes from [Mr LM's] cardiologist, Dr Leitl in order to establish the severity of his coronary artery disease;

(ii) document whether [Mr LM] was experiencing any cardiac symptoms and/or whether [Mr LM] was symptom-free;

(iii) document why [he] stopped prescribing the slow-release niacin to [Mr LM]; and

(iv) document whether [he] communicated to [Mr LM] the benefit of other conventional treatment and/or his response.

[3] Particular 1(c)(iii) of the allegations was effectively withdrawn by Counsel Assisting at the hearing.1

[4] The definitions of “unprofessional conduct” contained in section 3(1) of the Act, which are relevant to the Notice, are as follows:

“(a) professional conduct which is of a lesser standard than that which the  public might reasonably expect of a registered medical practitioner; or

(b) professional conduct which is of a lesser standard than that which might reasonably be expected of a medical practitioner by her or his peers;”

Chelation Therapy

[5] The Book of Evidence2 included four articles which described chelation therapy. Chelation therapy was also described in reports given by Dr S J Duffy on behalf of the Board and Professor A Sali on behalf of Dr Allen. It was not in dispute that chelation therapy involves the repeated intravenous administration of ethylene diamine tetra-acetic acid (“EDTA”), which is a synthetic amino acid. EDTA effectively removes heavy metals and minerals such as lead, copper and calcium from the blood and has been used since the 1950s to treat lead poisoning and toxicity from other heavy metals. Some physicians, such as Dr Allen, have recommended chelation therapy as a treatment for coronary artery heart disease (“CAD”).

[6] The Panel was not called upon to determine whether chelation therapy is a suitable treatment for CAD or whether it was a suitable treatment for Mr LM. It was accepted by both Counsel Assisting the Board and Dr Allen that chelation therapy was a form of treatment which was unproven in the sense that there had been inadequate controlled trials conducted which proved that it was effective for CAD and could also be described as experimental.3

[7] The Panel therefore proceeded on the basis that the use of chelation therapy for a patient such as Mr LM, who suffered from CAD, was an alternative and experimental therapy.

Dr Robert Bruce Allen

[8] Dr Allen’s curriculum vitae4 shows that he graduated with a MB BS from Melbourne University in 1964 and commenced practice in 1965. He has taught in the area of nutritional and environmental medicine since 1998 and was appointed as an Adjunct Professor of the Graduate School of Integrative Medicine at Swinburne University of Technology in April 2003. Dr Allen is a Fellow of the Australian College of Nutritional and Environmental Medicine, the Australian Society for Environmental Medicine and the Australian Medical Acupuncture College. He also has certifications from the International Board of Clinical Metal Toxicology and the International Board of Bio-oxidative Medicine in clinical metal toxicology and bio-oxidative medicine.

[9] In his evidence Dr Allen said that he became interested in the use of chelation therapy for CAD patients in or around the mid-1980s and he commenced practising in the therapy in the early 1990s. Dr Allen’s evidence was that the therapy is a relatively small part of his medical practice in the order of 10%.5

[10] An expert report submitted on behalf of Dr Allen described him as “an international expert to do with chelation therapy” and as having special expertise in relation to lifestyle and dietary advice.6

Mr LM

[11] Mr LM’s widow gave evidence about Mr LM before the Panel and in an affidavit.

[12] Mr LM was born in South Africa in 1944 and came to Australia in 1974. He studied metallurgical engineering at the University of Johannesburg and completed an equivalent to an MBA in the United Kingdom. Mr LM married in 1971 and had two daughters.

[13] Mr LM worked as a production manufacturing manager at an automotive company and as a senior manager undertook a company arranged health check on or around 26 March 1992. The results of that health check were contained in a written report dated 26 March 19927 which indicated that Mr LM’s “Cardiac Risk Rating” was in the high range and so Mr LM was referred to a cardiologist, Dr Leitl for review. At that time, Dr Leitl diagnosed CAD. After receiving this diagnosis, for reasons which will be discussed later, Mr LM determined that the cardiologist could not assist him. Mr LM continued his regular exercise programme and commenced a careful personal study about the disease and treatments. In or about 1993, based on his reading, Mr LM started to self-medicate with large amounts of vitamins and minerals and also changed his diet. In or about 1996 Mr LM read about chelation therapy on the Internet. Also via the Internet, Mr LM located the only doctor practising chelation therapy in Melbourne, Dr Allen. He commenced treatment with Dr Allen in July 1997 and continued to receive regular treatments from Dr Allen’s staff until 16 August 1999.

[14] Mr LM died on 22 August 1999 while cycling. The ambulance reports state that the cause of death was “cardiac arrest”.8 While the death certificate was not before the Board, it is understood that it was signed by Dr Allen and his best recollection was that he gave the cause of death as “a cardiovascular event of some kind, because that’s what it sounded like at the time, from the description” given by the ambulance service. Dr Allen said he was happy to complete the death certificate to assist the family even though he had not seen Mr LM for some four months.9 It may be noted that Dr Allen did not notify the coroner that Mr LM had received chelation therapy a week before he died.10

The Notification

[15] On 5 March 2002 the Board received a letter of complaint from Mr LM’s widow. After describing the background to Mr LM’s illness and his approach to it, she expressed concern about the chelation therapy. She said:

“It is now extremely painful for me to realise the extent to which we were both lulled into a false sense of security by the chelation. I have gone over in my mind a thousand times what I should have done to keep him alive. May be if we had not known of chelation [Mr LM] would have resorted, however reluctantly, to conventional medicine and would have continued to wear the pulse monitor and keep his heart beat below 130. He stopped wearing it because he felt so well. He died cycling.

In the grief of the moment, to my subsequent regret, we did not want to have an autopsy done.

I don’t believe [Mr LM] was ever advised by Dr Robert Allen to have another angiogram to find out whether the chelation had been effective. In my sorrow now, I am outraged that it was not insisted upon and also, that he was not advised to continue to keep his heart rate down with the help of the pulse monitor.

I now believe that chelation is a farce and that money earned from it is fraud. I believe that the false sense of security it gave us cost [Mr LM] his life.”

[16] Ms AS also expressed concerns about Dr Allen’s response to her when she notified him about Mr LM’s death and about his failure to encourage her to agree to an autopsy. While the Panel appreciated that these matters caused distress to Ms AS, as they were not the subject of any allegation in the Notice, the Panel did not consider them further.11

Mr LM’s Knowledge of and Approach to CAD

[17] Evidence about Mr LM’s knowledge of CAD and his approach to the illness and treatment options came from his widow, Dr Leitl and Dr Allen.

[18] It was apparent to the Panel that Mr LM was regarded by both Dr Leitl and Dr Allen as having a far greater than usual knowledge and understanding about CAD as compared to other patients. Dr Leitl’s evidence was that Mr LM was a very well informed person who understood what was being said to him about the illness. He also said that Mr LM was unhappy about having an illness, did not want to be operated on and “hated the medical profession and made it obvious”.12

[19] Dr Allen said that Mr LM was “probably one of the most informed patients I’ve ever had . . . He’d read very extensively and had a very good idea of what [chelation therapy] was all about” in relation to its use in CAD.13

[20] Ms AS and Dr Allen gave evidence that Mr LM understood from his first consultation with Dr Leitl that Dr Leitl had said that there was nothing he could do for Mr LM and that Mr LM would return in about 5 years for bypass surgery.14 Ms AS said in her affidavit and initial notification that Mr LM was infuriated by the perceived dismissiveness of Dr Leitl and abhorred the idea of having an operation. Dr Allen’s evidence was essentially the same in terms of what Mr LM said about the consultation with Dr Leitl.

[21] In her affidavit Ms AS also states that Mr LM said he was told by Dr Leitl that he should not let his heart rate exceed 110 beats per minute and that Mr LM wore a heart monitor for a few years but then gave up because he felt so well. Mr LM also told Ms AS that he had pushed his heart rate to 150 beats per minute with no adverse symptoms and that he found the rate of 110 frustrating as it was too slow a pace.

[22] Included in Dr Leitl’s notes was an entry for 24 December 1998, which said that Mr LM had come to speak to him about an assessment for a pilot’s licence (discussed later). The note said in part “he now has no angina. He used to have left arm pain on exercise.”15 In her evidence Ms AS said that about a year before he died Mr LM referred to having left arm pain and she was surprised by this as she had thought he had not experienced any symptoms.16

[23] Ms AS’s evidence was that Mr LM’s explanation to her and others about how chelation therapy worked was that the EDTA would unblock his artery by dissolving the substances that blocked the artery.17 By contrast, in Dr Allen’s evidence he stated that he would not have said that chelation therapy would unblock the artery. Dr Allen said he “usually” says to patients that the therapy will “slow down the process of ongoing disease. It will help improve collateral circulation.”18

[24] Ms AS gave evidence that Mr LM could not bear the idea of having surgery and possibly being left dependent and an invalid as a result. She also said that Mr LM used to say, “Nobody’s going to hack my chest open”.19

The Treatment of Mr LM

Initial treatment 1992–1993 - Dr Leitl

[25] Mr LM consulted Dr Leitl after the health check. Dr Leitl’s notes20 included a letter relating to the health check and copies of the health check report. It appears that Mr LM consulted Dr Leitl on or around 24 April 1992. A myocardial thallium stress test was performed by the St Vincent’s Hospital, Department of Nuclear Medicine on that day.

[26] In a letter to the Board concerning the notification, Dr Leitl said that the thallium test he ordered showed “an occlusion of the right coronary with bridge collaterals and retrograde filling from the left system. The left coronary had no significant disease.” 21

[27] Dr Leitl said that he had advised Mr LM regarding risk factors: “his cholesterol at the time of presentation had been in the high 8’s. [Mr LM] was warned about exercise, in particular to maintain heart rates of around 110 per minute, while exercising.”

[28] On 22 May 1992, Dr Leitl wrote to Mr LM enclosing a copy of the stress thallium and redistribution image report. The letter explained the images in comparatively technical language. Dr Leitl’s evidence was that he believed Mr LM had the technical expertise to understand what he was saying.22

[29] Dr Leitl also wrote to a general practitioner who was Mr LM’s family doctor asking that she take on the care of Mr LM, as he had no general practitioner. The letter included some background information and said:

“[Mr LM] has been advised against strenuous exercise. His ST segment changes on the electrocardiogram appear at around 100 beats per minute, and progress from there on. At peak exercise, he has 5 mm of ST segment depression.

[Mr LM] has been advised about his exercise patterns and his exercise tolerance. He has little in the way of risk factors, apart from a cholesterol of 8.3. There is no family history. He is not hypertensive, and not diabetic.

He has been commenced on Lopid. In the long term, [Mr LM] will in the time to come develop further disease. At the moment his symptoms are stable. His vessel is totally occluded, and not amenable to balloon dilation. His symptoms are trivial, and don’t warrant grafting.

I will be happy to help with his management in any way possible.”

[30] There was no evidence to show that Mr LM ever consulted that general practitioner about his CAD.

[31] In his evidence, Dr Leitl stated that he would not have said to Mr LM that he would require heart bypass surgery in a few years time because as at 1992 there was already data which suggested that bypass surgery was “on the way out”. Dr Leitl said that he would have told Mr LM that at worst he would require bypass grafting and at best he would “get away with tablets alone”. Dr Leitl also told Mr LM not to allow his heart rate to exceed 110 beats per minute while exercising. Dr Leitl said his usual practice was to teach patients to take their own pulse and he recommended heart rate monitors.23

[32] Dr Leitl reviewed Mr LM on 27 May 1993 and recommended that he commence small doses of aspirin in an effort to reduce the risk of further occlusion of his coronary arteries.

[33] Dr Leitl said that Mr LM was “lost to follow up” until he returned in 1998. He said that he considered that if Mr LM did not turn up for a review it was because he was ill or because he had chosen some other path or doctor. Dr Leitl said that Mr LM was a smart man who understood what he had been told and that he had enough intelligence to know that he needed some follow up care.24

[34] In December 1998, Mr LM returned to see Dr Leitl in relation to a test required for Mr LM to obtain a pilot’s licence from the Civil Aviation Safety Authority (“CASA”). The circumstances relating to the CASA test will be discussed in more detail later. At that time Dr Leitl told Mr LM that he would be required to undergo a stress test, a thallium examination and possibly an angiogram. Dr Leitl’s evidence was that he did not see Mr LM after that consultation.25

[35] Dr Leitl was also asked questions about the treatment of patients with CAD. In summary his evidence was as follows:

Mid-1992 – July 1997

[36] The primary evidence available to the Panel about Mr LM’s condition during the period mid 1992 to July 1997 came from Ms AS. In summary, her evidence was that:

[37] It appeared that Ms AS may have been mistaken as to her recollection of Mr LM taking aspirin regularly as none of the other evidence, including that of Dr Allen, indicated that Mr LM was taking aspirin as at July 1997 or thereafter. The evidence also suggested that no scripts for Lopid were written or filled for Mr LM after 1994.

July 1997 – August 1999

[38] Mr LM first consulted Dr Allen on 21 July 1997 and took with him what Dr Allen described as a “sheath” of ECG printouts from the 1992 stress test and the angiogram from that time. While Dr Allen said he reviewed those results, he did not retain a copy for his file. He could not explain why no copy was made and agreed with the proposition made by his counsel that it would have been preferable for him to have done so. He said “My normal procedure, if a patient comes with previous tests, as the other doctors have said that have given evidence here, you don’t want to re-invent the wheel”.28

[39] Dr Allen said that at the initial consultation the following occurred:

[40] After this initial consultation blood tests were arranged. Mr LM signed Dr Allen’s Informed Consent document on 1 August 1997 and the chelation

[41] The treatments were not given by Dr Allen but he said that he would often see Mr LM while he was having the treatment (which could take up to three hours) and chat to him.30 The total cost for the treatments was $5,400, that amount not being claimable via either Medicare or Mr LM’s private health insurance.31

[42] Some time was spent at the hearing reviewing the various blood test results and the levels shown. In summary:

[43] Dr Allen’s evidence was that when he saw Mr LM next after the 21 July consultation, having reviewed the blood test results, he “would have talked to him about [the cholesterol test results] and discussed the problem with him and the need to do something about it, because both his cholesterol and his triglycerides are significantly elevated.”36 When asked to explain further, he said that he meant they should be treating those levels. It is understood that this discussion was said to have been held on 30 September 1997.

[44] At that consultation Dr Allen recommended a slow release form of Niacin for Mr LM. No dose was recorded in his notes. Dr Allen explained that it had been used for many years as a lipid lowering agent and that there had been a number of studies done on its effectiveness including one conducted in 1986 which showed that it was as effective in lowering cholesterol as fibrates and better than other medications (such as statins and fibrates) in lowering triglycerides.37 The Niacin was imported by Dr Allen on behalf of his patients and was sold to Mr LM by Dr Allen.38 In response to a question from the Panel, Dr Allen agreed that Niacin was the “main-stay” of his treatment in relation to lipids.39

[45] Then next consultation was on 24 February 1998 and at that time, as indicated earlier, the blood test results in terms of both cholesterol and triglycerides were high. Dr Allen’s evidence was that at that time he became concerned as to whether the results indicated that Mr LM had a condition known as “syndrome X”. Dr Allen described syndrome X as a “pre-diabetic problem” where there is a decreased functioning of the insulin receptors on cells which lead to high insulin levels which stimulate the production of both cholesterol and triglycerides. In response to these concerns, Dr Allen added additional materials including magnesium and chromium to the EDTA mixture with the intention that these may help control the lipids by dealing with any potential insulin resistance.40

[46] In cross-examination Dr Allen conceded that he did not properly diagnose whether Mr LM had syndrome X. He also agreed that another reason why the levels remained high was potentially because the dose of Niacin was too low. When asked whether he increased the Niacin dose at that time, Dr Allen said, “I can’t recall definitely but I suspect I did somewhere round about there. We would have pushed the dose up a bit.”41

[47] In relation to the results and any discussion with Mr LM at the February 1998 consultation, Dr Allen said that “I may well have – I may well have discussed them with him in passing,” but agreed with Counsel Assisting that he did not know if in fact that had happened42

[48] Dr Allen next saw Mr LM on 22 May 1998. His evidence under cross-examination was that, as the most recent blood tests showed Mr LM’s magnesium to be low, he “would have” increased the magnesium dose in the EDTA mixture although he agreed that he could not be 100% sure he did so.43

[49] Dr Allen next saw Mr LM on 16 October 1998. Mr LM asked Dr Allen to complete a Civil Aviation Medical Report (“CASA Report”) so that he could commence flying lessons. Ms AS said in her evidence that Mr LM had dreamed of flying since he was a teenager and keeping his licence was very important to him.44

[50] It is not necessary to set out in detail each of the matters covered by the CASA Report,45 but the following may be noted:

[51] After the report was submitted to CASA, a letter was issued to Mr LM stating that he was required to be assessed by a cardiologist. Dr Allen’s evidence was that Mr LM refused to do so and he noted on his copy of the letter seeking a cardiologist’s review “Not pursued – PT does not want review by cardiologist.”50 A referral was written to Dr Leitl by Dr Allen but he was unaware until this matter arose that Mr LM had in fact attended Dr Leitl, as was outlined above.

[52] Dr Allen’s evidence regarding the CASA report he completed was that he was aware that the decision as to fitness was a matter to be determined by CASA according to its guidelines and he was aware that it was likely that CASA would query Mr LM’s heart condition. Dr Allen denied the proposition put by Counsel Assisting that the contents of the CASA report were misleading and that in the context of the CASA report it was not incorrect to say that there was no need for Mr LM to be referred to a specialist. 51

[53] Dr Allen’s final consultation with Mr LM was on 16 April 1999 although the final chelation therapy was administered after that date. Dr Allen’s evidence was that at that time Mr LM was well, he was walking or cycling up to 12 kilometres per day and that Mr LM “was basically on top of the world.”52 Dr Allen also said that the cholesterol reading was up and that again he talked about that and that Mr LM said words to the effect that he was not going to do anything differently.53

[54] There was a large amount of other evidence given by Dr Allen in-chief, under cross-examination and in response to questions from the Panel regarding his treatment of Mr LM. Relevantly, Dr Allen’s evidence was that:

[55] The consent form signed by Mr LM in 1 August 1997 was before the Panel. The contents of the form include the following:

“I [Mr LM] have been informed by my physician that EDTA chelation therapy for treatment of arteriosclerotic vascular disease and/or heavy metal poisoning(s) will be administered at my request and on my physician’s recommendations. My physician has informed me that other modes of therapy have been used for the treatment of these conditions.

I have read all the above and have had other information given to me about chelation treatment so that I feel that I fully understand what I am signing and I hereby request and consent to receive these treatments.”64

[56] Dr Allen said in response to a question from the Panel that his discussion about the other modes of treatment with patients was to the following effect:

“I would talk to them about the possibilities of medication, lipid lowering agency if necessary; aspirin or something of that kind if necessary; beta blockers if there’s an indication, like Dr Duffy was talking about this morning, for it; more recently the ACE inhibitors you would need to talk to them about, because they are now coming into play a little bit with this. Medications that one might use to treat congestive heart failure they might have. From there, looking at things like is it amenable to angioplasty or stenting. It is appropriate to use bypass and so on, and you go through the whole thing, and you say ‘These are the things that can be done’ and as I said there are times when I would say to them ‘No way’ [to giving chelation therapy].”65

[57] Dr Allen said that this consultation and discussion process could take up to an hour and a half to two hours.66

[58] In his evidence, Dr Allen said that the additional information given to patients included a pamphlet and a copy of a book about chelation therapy written by Lady Cilento. He said that patients usually took this material home to read and the consent form was signed on their return.

[59] Dr Allen said that the consent form had been changed to state that chelation therapy was “a controversial treatment, and that it is to a large extent considered as experimental.67

Dr Allen’s notes

[60] All of Dr Allen’s own notes for his treatment of Mr LM were before the Panel and were presented on one A4 sheet of paper.68 In addition, the Panel was given what was described as a transcript of the notes, but, in fact that document included additional comments added by Dr Allen later.69 The Panel gave no weight to the transcript document.

[61] The Panel also had before it records of the various treatments given to Mr LM and various blood test results.

[62] The notes for the first consultation held on 21 July 1997 contained Mr LM’s history, references to the vitamins he was taking and recorded the recommendation of Niacin. The notes did not, however, make any reference to the discussion Dr Allen said was held regarding the nature of the therapy and the fact that it was experimental and unproven, other modes of treatment or the test results Mr LM had taken with him.

[63] The notes recording the subsequent consultations were limited to little more than one line each. While they each stated that Mr LM was “well” or on one occasion that he felt better, there was no record of Dr Allen asking whether Mr LM had any pain or symptoms.

[64] In none of the entries was there a heart rate recorded and there were no records for the examination said to have been conducted for the CASA report. The notes did not contain a dosage for the Niacin prescribed by Dr Allen.

Evidence of Dr Stefan Duffy

[65] Dr Duffy gave expert evidence on behalf of the Board. Dr Duffy is a cardiologist at the Heart Centre at the Alfred Hospital and a Fellow of the Royal College of Physicians. He has worked at Guy’s Hospital in London and at Boston University Medical Centre. Dr Duffy described himself as having a special interest in vascular biology and has been involved in research on the functionality of blood vessels; why they develop coronary disease and how they behave once coronary disease develops.70

[66] Dr Duffy provided a report to the solicitors for the Board which responded to questions.71 The matters in the report most relevant to the allegations in the Notice of Formal Hearing may be summarised as follows:

[67] Dr Duffy also gave evidence before the Panel and was cross-examined. While his evidence in part repeated the matters contained in his report, there was also other evidence which was considered relevant to the Panel. That evidence included the following:

Report by Professor Avni Sali

[68] Professor Avni Sali gave expert evidence on behalf of Dr Allen in the form of a report78. Professor Sali is a professor at the Graduate School of Integrative Medicine, Swinburne University of Technology.

[69] His report may be summarised as follows:

Evidence by Dr Allen

[70] Dr Allen’s evidence in many respects was unsatisfactory. It was not surprising that he did not have a detailed recall of his treatment of Mr LM for an approximate period of two years some six to eight years ago. However, it appeared to the Panel that his responses to many questions were in fact reconstructions – Dr Allen repeatedly used the phrases “I would have” and “I probably”. When pressed on some matters Dr Allen conceded he could not in fact recall what was said or done. Another unsatisfactory aspect of the evidence was that the reconstructions at times appeared to adopt what had been said in evidence earlier by Dr Leitl and Dr Duffy.

[71] Accordingly, the Panel treated some of Dr Allen’s evidence with caution and gave weight to his contemporaneous notes.

Findings - Management

[72] The first allegation contends that Dr Allen engaged in unprofessional conduct in that he failed to adequately manage Mr LM’s CAD.

[73] Some broad comments may be made about the question of management. While strictly speaking Dr Allen may not have been Mr LM’s general practitioner, it is apparent from the evidence that he was the medical practitioner giving Mr LM primary care in relation to his CAD. On Dr Allen’s own evidence it was known to him that Mr LM was not seeing a cardiologist and in fact until the hearing process began, he was unaware that Mr LM had returned to see Dr Leitl in 1998.

[74] In circumstances where Dr Allen was the primary physician, it is the Panel’s view that he had a responsibility to ensure that he addressed all aspects of Mr LM’s CAD and that he was not entitled to limit himself to providing the chelation therapy Mr LM had sought. It was the Panel’s view that in his treatment of Mr LM Dr Allen in a sense forgot his broader role as Mr LM’s treating physician and so failed to take a sufficiently overall view about Mr LM’s illness and treatment options, particularly in regard to his progress and prognosis.

[75] Counsel Assisting submitted that Dr Allen ought to have used his therapeutic authority to ensure that Mr LM was aware of what was required to adequately treat him and to “plead with the patient [and] use all of his powers of persuasion”.79 The Panel agreed with that submission. Dr Duffy said that he believed even where the patient was resistant to a proposed treatment it was appropriate to explain why the treatment was considered necessary and in some circumstances write a prescription and suggest that the patient seek a second opinion or write a letter to the patient a letter explaining why the treatment was recommended. In the Panel’s view Dr Duffy was quite correct to describe the need at times to try to persuade patients who do not have symptoms that they have a chronic disease which requires ongoing treatment.

[76] While here it appears correct to say that from the first consultation Mr LM had a strong resistance to treatment of the type undertaken and recommended by Dr Leitl, the Panel had the sense that Dr Allen acceded to that position thereafter and offered Mr LM the treatment he wanted rather than what was required to adequately treat Mr LM’s condition. This view is supported by Dr Allen’s own evidence about his patients. He referred to seeing a number of patients who are disenchanted with the medical system for a variety of reasons and said that he tried “to do [his] best to find a way to help these people.” He later referred to having patients continue to take lipid lowering agents “If the patients are happy with doing it and there’s no other reason not to.”80 This evidence indicated to the Panel that Dr Allen had a misapprehension as to his role as a medical practitioner when treating patients with serious illnesses.

[77] The Panel also has serious concerns about the manner in which Dr Allen completed the CASA Report but as that was not the subject of any of the allegations, no further comment is required.

[78] The allegation refers specifically to two matters, which are dealt with separately.

Conventional cardiac medications

[79] The evidence of Dr Duffy, which was supported by that of Dr Leitl, was that conventional treatment for a patient such as Mr LM during the period 1997 to 1999 included treatment with daily aspirin and a lipid lowering medication from the statins group. It is quite clear that at no time did Dr Allen prescribe either of those medications.

[80] While Dr Allen may have regarded the self-prescribed vitamin E taken by Mr LM together with the EDTA solution as having the same effect, the evidence before the Panel did not support his view. The Panel was satisfied that, as from at least 1997, there was overwhelming evidence available to practitioners such as Dr Allen to indicate that all patients with CAD ought to be prescribed aspirin. The Panel did not regard as adequate the practice Dr Allen apparently adopted which was to have patients continue with aspirin if it had been prescribed by another practitioner but not to otherwise recommend or prescribe it to others.

[81] The allegation also concerns whether Dr Allen recommended conventional medications to Mr LM. In Dr Allen’s evidence and his Counsel’s address, much was made of the fact that Mr LM had a resistance to taking conventional medications. Dr Allen referred to Mr LM expressing concerns about the side effects associated with lipid lowering drugs. There was no evidence from Dr Allen or Ms AS to indicate that Mr LM experienced concerning side effects from the Lopid which was prescribed by Dr Leitl. As was noted by Dr Duffy, as there was no evidence that Mr LM had taken any of the statin drugs, it is difficult to see on what basis Mr LM would have concluded that he could not have tolerated side effects.

[82] While reliance was placed on the emails Mr LM sent regarding alternative medications without side effects, it must be noted that they were sent in early 1999 and so cannot necessarily be regarded as indicating his view in 1997. Ms AS’s evidence was that Mr LM never discussed with her in any respect cholesterol lowering medications.81 Having said that, it is more likely than not that Mr LM was aware of the importance of those medications and may have been unwilling to take them. While Dr Allen stated emphatically that he never told patients that chelation therapy would unblock an occluded artery, it may be that Mr LM had a belief that it would have that or some similar effect such that these other medications were not required. The Panel has formed no particular view regarding these matters because clearly no evidence was available from Mr LM.

[83] Given that Dr Allen considered the Niacin he sold to Mr LM to be an effective medication to manage raised lipids, it seems unlikely that he would have recommended any other medication.

[84] The Panel was certainly not satisfied that Dr Allen recommended with the required level of explanation or persuasiveness that Mr LM take a lipid lowering medication such as from the statin group. In the Panel’s view even if that arose because of Dr Allen’s understanding of what medications Mr LM was prepared to take or consider, his approach could not be described as adequate management.

Assessment or review

[85] The second part of allegation 1(a) refers to a failure to complete an assessment or review of Mr LM given certain knowledge held by Dr Allen.

[86] Taking into account Dr Allen’s notes and evidence and also the evidence of Dr Duffy as to what is required when a new patient first presents, Dr Allen’s initial review of Mr LM was adequate with two exceptions. There was no record of him taking Mr LM’s blood pressure at that time and so it appears quite possible that it was not done. Dr Allen’s evidence was that he did so “normally fairly routinely” and that if it was normal he did not make a note of it, as there was “nothing specific to say”.82 More importantly no arrangement was made for Mr LM to have a further stress ECG to allow Dr Allen to assess Mr LM’s current situation compared with the copies of the tests Mr LM brought with him from 1992. Both Dr Duffy and Dr Leitl were of the clear view that a further ECG was required at that stage.

[87] The Panel was of the view that Dr Allen failed to undertake an adequate assessment or review of Mr LM thereafter. As has been discussed in these reasons, Dr Allen relied on his staff to take blood pressure readings and there is no indication that he repeated that test each time he saw Mr LM. In addition, the blood tests ordered by Dr Allen to measure Mr LM’s lipid levels were not fasting tests and it is the Panel’s view that a failure to take at least some fasting samples meant that Dr Allen did not have sufficiently accurate information on which to base an assessment. The Panel also had concerns about the fact that it appeared to be Dr Allen’s practice to encourage patients to eat before and during treatments and then rely on blood tests taken after food.

[88] The evidence of both Dr Duffy and Dr Leitl was that, when the blood test results indicated that the Niacin was not effective in reducing the lipid levels, that fact taken with Mr LM’s history indicated further investigations were required. As discussed earlier the Panel appreciated that Mr LM was a patient who had strong views about his treatment and what he was prepared to do. This was shown by his willingness not to pursue flying because tests were required. However, the Panel considered it to be incumbent on Dr Allen to, recommend tests, in the strongest possible terms, particularly in 1998 when he said in evidence he was very concerned about Mr LM. It may be that Dr Allen’s mistaken belief that he could not arrange a stress ECG test himself limited how strongly he recommended this course of action. The Panel was not satisfied that by giving Mr LM a referral to Dr Leitl in the context of the CASA testing Dr Allen adequately managed the serious concerns he had about Mr LM’s then condition.

Unprofessional conduct

[89] The Panel is of the view that Dr Allen’s conduct in relation to the management of Mr LM’s CAD as described in allegation 1(a) amounted to unprofessional conduct under paragraphs 3(1)(a) and (b) of the definition of “unprofessional conduct” in the Act.

Finding – disclosure

[90] While the Panel was not satisfied on the evidence that Dr Allen gave Mr LM a detailed explanation about the fact that chelation therapy was of unproven benefit to patients and was experimental, it did consider that the particular knowledge of Mr LM was relevant to what would be regarded as “adequate” for him. It appears most likely that Mr LM was well aware as a result of his own research that chelation therapy was unproven and experimental. It is also accepted that it would have been apparent to Dr Allen that Mr LM was a very knowledgeable patient in terms of chelation therapy. In these circumstances the Panel cannot conclude that any shortcomings in the advice given by Dr Allen to Mr LM could support an allegation of unprofessional conduct.

[91] The Panel notes though that the consent form signed by Mr LM could not be regarded of itself as providing adequate advice about these matters.

Findings - documentation

[92] The Notice of Formal Hearing alleged that Dr Allen failed to adequately document in his clinical notes his findings and management of Mr LM in particular ways. Counsel Assisting referred the Panel to the decision of another Panel of the Board in relation to Dr Lai.83 In that case the Panel concluded that Dr Lai had engaged in unprofessional conduct including in relation to his note taking. The Panel made a number of comments about the importance of keeping proper medical records and in particular at paragraph 64 said:

“The Panel wishes to make it clear in these reasons that it does not make a judgement on the use of alternative medicines in the treatment of patients, but it does hold the view that the more unorthodox the treatment, the more the doctor must be able to justify that treatment by what is recorded in medical records, and on the basis of his research and inquiry into the safety and efficacy of that treatment.”

[93] The Panel endorses those comments.

Obtaining reports and documenting symptoms

[94] The evidence showed that Dr Allen did review certain materials given to him by Mr LM. Those materials included printouts from Mr LM’s 1992 stress test, thallium and his angiogram. While the Panel regarded Dr Allen’s failure to keep a copy as poor practice, it did not of itself amount to unprofessional conduct. Taking into account Dr Duffy’s evidence that those materials would have been sufficient for a medical practitioner to understand the previous investigations which had been done. the Panel does not consider that Dr Allen’s failure to make further enquiry of Dr Leitl amounts to unprofessional conduct.

[95] Dr Allen’s evidence was that he asked Mr LM whether he had any symptoms and, in the absence of any being reported, he recorded Mr LM as being “well” in his notes. While the Panel had some concerns about the degree to which Dr Allen enquired about Mr LM’s symptoms and overall well being and accepted Dr Duffy’s evidence that it was important to record specific responses to questions about these matters, it did not consider that the brevity of Dr Allen’s notes as described in allegation 1(c)(ii) constitutes unprofessional conduct.

Communication of benefits of conventional treatments

[96] A review of Dr Allen’s notes makes it clear that there was no documentation of him communicating to Mr LM the benefit of other conventional treatment or his response.

[97] There was a note written on the CASA letter to Mr LM about the need for further tests made by Dr Allen but that note does not show that Dr Allen recommended those tests in general terms or even in the context of the CASA application.

[98] Having regard to the content of the consent form signed by Mr LM and the evidence about it, the Panel does not consider that it adequately documents the communication by Dr Allen to Mr LM with respect to the benefits of the conventional treatments discussed.

[99] The Panel gave weight to the clear evidence that Mr LM ought to have been prescribed lipid lowering medications and aspirin, the evidence of Dr Duffy about recording a patient’s refusal to accept a recommended course of treatment and the decision in Lai.

[100] It is the Panel’s view that the failure to record what was said about those medications and Dr Allen’s own concerns about the need for further tests in 1998 was extremely poor practice. If in fact those medications or further tests were recommended by Dr Allen and Mr LM refused to take them, a record of that discussion ought to have been made. While it was suggested by Dr Allen’s Counsel that notes of that type are primarily directed at protecting a medical practitioner from a legal claim, the Panel considers that there are other important reasons why more detailed records are required not the least of which is to ensure that a subsequent treating doctor can understand the rationale for the approach to treatment.

[101] The Panel is of the view that Dr Allen’s conduct in relation to the documentation of his discussion of the benefits of conventional treatments and Mr LM’s responses as described in allegation 1(c)(iv) amounts to unprofessional conduct under paragraphs 3(1)(a) and (b) of the definition of “unprofessional conduct” in the Act.

Unprofessional conduct of a serious nature

[102] Having concluded that Dr Allen has engaged in unprofessional conduct within allegations 1(a) and (c)(iv) of the Notice of Formal Hearing, the Panel considered whether that unprofessional conduct was of a serious or not serious nature.

[103] Counsel Assisting drew the Panel’s attention to the decision in Parr v Nurses' Board of Victoria in which Kellam J said:

“In my view the question of whether or not a nurse has engaged in unprofessional conduct of a serious nature must depend on the facts of each case. Clearly such conduct would not be serious if it was trivial, or of momentary effect only at the time of the commission or omission by which the conduct was so defined. It must be a departure, in a substantial manner, from the standards which might be reasonably expected of a registered nurse. The departure from such standards must be blameworthy and deserving of more than passing censure.”84

[104] When considering whether the unprofessional conduct of Dr Allen was of a serious nature the Panel was mindful of the following matters:

[105] In the Panel’s view in the circumstances Dr Allen has engaged in unprofessional conduct of a serious nature under section 45A(1)(a) of the Act.

Determination

[106] Submissions were made by both Counsel Assisting and Dr Allen’s Counsel as to the appropriate determination to be made under section 45A(2).

[107] Counsel Assisting made the following submissions:

[108] In Dr Allen’s Counsel’s address reference was made to Dr Allen’s long period of practice (in excess of 23 years), his age and his family circumstances. It was said that Dr Allen’s was a general practice in which he saw in the order of 12 to 15 patients per day in usually long consultations. It was said that the patients were “people who come to him when other modalities of treatment have not proved to be of benefit”87 including patients with cancer.

[109] Dr Allen’s Counsel asked the Panel to have regard to the entire history of the matter and why Dr C had approached Dr Allen for treatment. It was also noted that in terms of the allegation dealing with documentation, only one of the four particulars was made out and it was conceded that Dr Allen’s note taking was not good. It was then submitted that the appropriate course of action for the Panel was for Dr Allen to be cautioned and that “no useful purpose would be served . . . either to Dr Allen or to the public or to the profession by requiring [Dr Allen] to undergo counselling or further education or training or anything of that sought.”88

[110] The Panel considered the submissions made in the context of its primary role which is to protect the public.

[111] The Panel determines pursuant to section 45A(2)(a) of the Act that Dr Allen is to undergo counselling, that counselling to be provided by a senior medical practitioner approved by the Deputy CEO of the Board and to involve at least three sessions to be completed within a period of six months, the counselling to be paid for by Dr Allen.

[112] The counselling is to include the following areas:

  1. An assessment of five randomly selected patient files where the patient consents to this assessment;
  2. The management of CAD including appropriate medical therapy;
  3. The importance of continuing conventional evidence-based medication during any alternative treatments; and
  4. The importance of documenting the rationale of alternative treatments in his notes.

[113] At the completion of the counselling, a report is to be provided to the Board by the counsellor. Dr Allen is also required to provide a report to the Board, outlining what he has learnt from the process of counselling.

[114] In addition, the Panel reprimands Dr Allen pursuant to section 45A(2)(c) of the Act for his failure to adequately manage the conventional cardiac treatment of Mr LM.

Mr W F Johnson
Chair
3 June 2005

Footnotes

  1. Transcript, at p. 241
  2. Exhibit A
  3. (Counsel Assisting) Transcript, at pp. 34-35; (Counsel for Dr Allen) Transcript, at p. 246; (Dr Allen) Transcript at p. 158
  4. Exhibit 2
  5. Transcript, at pp. 154-155
  6. Report of Professor Avni Sali, Graduate School of Integrative Medicine, Swinburne University of Technology, Exhibit 3
  7. Exhibit JB-1 to an affidavit sworn by Ms AS on 8 September 2003, Book of Evidence, Tab 14
  8. Book of Evidence, Part B, Tab 13
  9. Transcript, at pp. 216-217
  10. Transcript, at p. 217
  11. Exhibit JB-3 to an affidavit sworn by Ms AS on 8 September 2003, Book of Evidence, Tab 14. The reference to 130 beats per minute apparently ought to have been 110 beats per minute.
  12. Transcript, at p. 98
  13. Transcript, at p. 156
  14. Ms AS Transcript, at p.40; (Dr Allen) Transcript, at p.155
  15. Book of Evidence, Tab 12
  16. Transcript, at pp. 54-55 7
  17. Transcript, at pp. 44, 50-51
  18. Transcript, at p. 157
  19. Transcript, at p. 57
  20. Exhibit B
  21. Letter dated 21 November 2003, Book of Evidence, Part B, Tab 11
  22. Transcript, at p. 74 8
  23. Transcript, at pp. 74; 80-81 and 94-95
  24. Transcript, at p. 82
  25. Transcript, at pp. 88-89; Exhibit B
  26. Transcript, at pp. 76–83 and 85-86 27 Transcript, at pp. 42–43; 47–48 and 54-55
  27. Transcript, at pp. 42–43; 47–48 and 54-55
  28. Transcript, at pp. 156-157
  29. Transcript, at pp. 155-159
  30. Transcript, at pp. 157 and 181
  31. Exhibit JB-2 to an affidavit sworn by Ms AS on 8 September 2003, Book of Evidence, Tab 14
  32. Exhibit 1 – these lowest and highest readings are consistent with the Chronology prepared by Counsel Assisting
  33. Transcript, at pp. 181-182
  34. Transcript, at p. 83, referring to blood test results as at July 1997
  35. Transcript, at pp. 84-85
  36. Transcript, at p. 160
  37. Transcript, at p. 161
  38. Transcript, at p. 191 and Exhibit JB-2 to an affidavit sworn by Ms AS on 8 September 2003, Book of Evidence, Tab 14
  39. Transcript, at pp. 226-227
  40. Transcript, at pp. 162-163
  41. Transcript, at pp. 178-179
  42. Transcript, at p. 181
  43. Transcript, at p. 182
  44. Transcript, at p. 65
  45. Exhibit D
  46. Transcript, at pp. 195 and 202
  47. Transcript, at pp.191-192
  48. Transcript, at p. 204
  49. Transcript, at pp. 166 and 184
  50. Letter from CASA to Mr LM dated 18 November 1998, Book of Evidence, Tab B 6
  51. Transcript, at pp. 199-200 and 205
  52. Transcript, at p. 167
  53. Transcript, at p. 168
  54. Transcript, at pp. 163; 207
  55. Transcript, at pp. 163 and 176-177; Book of Evidence Tab 20-22
  56. Transcript, at p. 196
  57. Transcript, at p. 185
  58. Transcript, at pp. 185; 215 and 231-232
  59. Transcript, at p.170;
  60. Transcript, at pp.214-215
  61. Transcript, at p.226
  62. Transcript, at pp.212-213
  63. 63.. Transcript, at p.173
  64. Book of Evidence, Tab 6
  65. Transcript, at pp. 218-219
  66. Transcript, at pp. 218 - 219
  67. Transcript, at p. 208
  68. Book of Evidence Tab 6
  69. Book of Evidence, Tab 7; Transcript, at pp. 210 - 211
  70. Transcript, at pp. 105-106
  71. Book of Evidence, Tab 15
  72. Transcript, at pp. 112-114
  73. Transcript, at p. 134
  74. Transcript, at pp.118-119
  75. Transcript, at p. 130
  76. Transcript, at p. 117
  77. Transcript, at pp. 106-141
  78. Exhibit 3
  79. Transcript, at p. 245
  80. Transcript, at pp. 170-171
  81. Transcript, at p. 57
  82. Transcript, at p. 225
  83. Re: Dr John Chun-Tsang Lai [2003] MPBV 30
  84. Parr v Nurses Board of Victoria (1998) 16 VAR 118 27
  85. Transcript, at p.2, 3 May 2005
  86. Transcript, at p.2-5, 3 May 2005
  87. Transcript, at p.6, 3 May 2005
  88. Transcript, at p. 5-7

This page was posted on July 1, 2005.

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