Download Reasons for Decision

DR MALCOLM ADAMS TRAILL
By Application for Review dated 20 October 2005 and filed with the Victorian Civil and
Administrative Tribunal (“VCAT”) on that date, Dr Malcolm Adams Traill seeks to review
the determination of a Panel of the Medical Practitioners Board of Victoria made on 19
October 2005 that his registration as a medical practitioner be cancelled, effective from
5:00pm 26 October 2005, and he be disqualified from applying for registration for a
period of three years from that date.
On 28 October 2005, the VCAT ordered that the operation of the determination be
stayed pending final determination of the Application for Review, upon Dr Traill
undertaking to the Tribunal not to:
A.
treat any patient with any form of hyperthermia or 434 mghz microwave
therapy;
B.
hold himself out as an oncologist;
C.
treat any patient with any form of chemotherapy.
The Application for Review is to be fixed for hearing on a date not before 1 April 2006.
The Reasons for Decision of the Panel of the Board follow this page.
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MEDICAL PRACTITIONERS BOARD OF VICTORIA
Re: Dr Malcolm Adams Traill [2006] MPBV 1
Reasons for Decision
Before:
Dr G D Kerr (Chair)
Dr Q De Zylva
Ms K Sanders
Ms A Dea
Appearances:
Assisting the Panel:
Mr C O’Neill of Counsel instructed by Minter
Ellison, Lawyers
For the Practitioner:
In person
Dates of Hearing:
26, 27 & 28 April 2005, 18 & 19 July 2005, 17 & 19
October 2005
Date of Decision:
19 October 2005
Findings:
1.
Dr Traill engaged in unprofessional conduct within the meaning of paragraphs
3(1)(a) and/or 3(1)(b) and/or 3(1)(c) and/or 3(1)(e) of the definition of
"unprofessional conduct" in the Medical Practice Act 1994 (“the Act”) in that,
during the period on or about 23 September 2000 to 27 November 2000, he
failed to exercise the care and skill of a competent medical practitioner in his
treatment of his patient, Ms SO, who was diagnosed in August 2000 with small
cell carcinoma of the lung;
2.
Dr Traill engaged in unprofessional conduct within the meaning of paragraphs
3(1)(a) and/or 3(1)(b) and/or 3(1)(c) and/or 3(1)(e) of the definition of
"unprofessional conduct" in the Act, in that between 22 January and 9 February
2001, he failed to exercise the care and skill of a competent medical practitioner
in his treatment of his patient, Ms ST, who suffered from recurrent cutaneous
metastatic breast cancer of the right breast; and
3.
Dr Traill engaged in unprofessional conduct within the meaning of paragraphs
3(1)(a) and/or 3(1)(b) and/or 3(1)(c) and/or 3(1)(e) of the definition of
"unprofessional conduct" in the Act, in that during the period on or about October
3
and November 2001, he failed to exercise the care and skill of a competent
medical practitioner in his treatment of his patient, Master TU, a five-year-old
child with a malignant brain tumour, a widely disseminated anaplastic
ependymoma; and
4.
That unprofessional conduct was of a serious nature pursuant to section
45A(1)(a) of the Act.
Determinations
1.
The unanimous determination of the Panel is that Dr Traill is reprimanded for his
conduct pursuant to section 45A(2)(c) of the Act.
2.
Further the Panel (by majority, Dr De Zylva dissenting) has determined that Dr
Traill’s registration is to be cancelled pursuant to section 45A(2)(h) of the Act and
that cancellation is to come into effect at 5 pm on Wednesday, 26 October 2005.
The majority also determined pursuant to section 45A(2)(i) of the Act that Dr Traill
is disqualified from applying for registration under section 5 of the Act for a period
of three years.
4
Reasons for Decision
The Medical Practitioners Board of Victoria (“the Board”) determined under section 46 of
the Medical Practice Act 1994 (“the Act”) that a Formal Hearing was to be held into the
professional conduct of Dr Traill. A Panel was convened and the hearing was held on
26, 27 & 28 April 2005, 18 & 19 July 2005 and 17 & 19 October 2005.
The allegations heard by the Panel were contained in an Amended Notice of Formal
Hearing (“Notice”). The Panel was required to determine whether Dr Traill:
“1. . . engaged in unprofessional conduct within the meaning of paragraphs 3(1)(a)
and/or 3(1)(b) and/or 3(1)(c) and/or 3(1)(d) and/or 3(1)(e) of the definition of
"unprofessional conduct" in the Act, in that:
(a)
During the period on or about 23 September 2000 to 27 November
2000, [he] failed to exercise the care and skill of a competent medical
practitioner in [his] treatment of [his] patient, Ms SO, who was
diagnosed in August 2000 with small cell carcinoma of the lung.
Particulars
(i)
On or about 23 September 2000, [he] recommended to [his]
patient a treatment called full body hyperthermia treatment,
which treatment was not beneficial or effective for a patient
with potentially curable cancer;
(ii)
[He] failed to provide [his] patient with adequate information to
obtain her informed consent to the treatment, including [his]
failure to advise her that her withdrawal from the planned
chemotherapy cycles could adversely effect her health and
prognosis and that the most efficacious treatment for her
cancer was cytoxic chemotherapy and thoracic radiation;
(iii)
[He] provided UHF 434 Mghz microwave therapy treatment for
[his] patient, which treatment was not beneficial nor effective
for a patient with potentially curable cancer;
(iv)
[He] charged the Health Insurance Commission for 15
professional services for item 13915, cytoxic chemotherapy,
intravenous (less than one hour) but did not administer this
treatment to [his] patient at all;
(v)
On or about 5 October 2000 until the end of October 2000,
[he] prescribed lithium to the patient, an experimental
treatment, administered under [his] knowledge and
5
supervision, that was unnecessary or not reasonably required
in the treatment of [his] patient;
(b)
(vi)
[He] failed to monitor the level of lithium in the patient's blood;
(vii)
[He] charged [his] patient a sum of between $6,500 - $7,000
for [his] treatment of the patient which did not attract any
Medicare rebate, which in the circumstances of the patient
was excessive;
(viii)
[He] failed to adequately follow up [his] treatment of [his]
patient;
(ix)
[He] claimed to the patient to be an oncologist, but [he] did not
have any formal oncology qualification or recent oncologic
training;
(x)
[He] failed to adequately monitor [his] patient during [his]
treatment in so far as [he] monitored the effect of [his]
treatment by testing the patient's uric acid levels, such
methodology having no support in the small lung cell literature.
Further, until requested by the patient, [he] did not request CT
scans or undertake adequate x-ray investigation of [his]
patient; and
(xi)
By pursuing an ineffective and time consuming treatment the
patient was denied proper medical advice and a potential
cure.
Between 22 January and 9 February 2001, [he] failed to exercise the
care and skill of a competent medical practitioner in [his] treatment of
[his] patient, Ms ST, who suffered from recurrent cutaneous metastatic
breast cancer of the right breast:
Particulars
(i)
[He] recommended treatment of her condition with microwave
hyperthermia and local hyperthermia treatment;
(ii)
[He] failed to provide the patient with adequate information to
obtain her informed consent to the treatment;
(iii)
Further, [he] provided her with 15 UHF 434 Mghz
hyperthermia treatments and 15 local hyperthermia
treatments, in circumstances where the treatment was an
ineffective, unproven mode of treatment for the patient's
condition;
(iv)
[He] failed to forward records of [his] treatment of the patient,
when requested by her treating surgeon in Tasmania in a
6
timely manner. Dr Linacre requested information from [him]
on 5 January 2001 and [he] replied to [Dr Linacre] on 29
March 2001;
(c)
(v)
[He] failed to investigate and diagnose lesions on the skin over
[the] Ms ST's right breast at the time of providing the treatment
to her;
(vi)
[He] failed to obtain a biopsy and histology of the lesions;
(vii)
[He] charged the patient the sum of $10,734.85 for treatment
which in the circumstances, was excessive; and
(viii)
[He] billed the Health Insurance Commission for item 13915
for the patient on the following dates: 22 - 26 January 2001,
29 [January] - 2 February 2001 and 5 - 9 February 2001 for
cytotoxic chemotherapy, administration, either by intravenous
push or intravenous infusion but did not provide the patient
with such chemotherapy treatment.
During the period on or about October and November 2001, [he] failed
to exercise the care and skill of a competent medical practitioner in
[his] treatment of [his] patient, TU, a five-year-old child with a malignant
brain tumour, a widely disseminated anaplastic ependymoma.
Particulars
(i)
[He] recommended treatment of TU's condition with UHF 434
Mghz treatment, a form of treatment that has not been
demonstrated to be efficacious for such a condition;
(ii)
By providing this treatment [he] potentially interfered in the
treating relationship between TU and his parents and Dr Peter
Downie, TU’s treating oncologist;
(iii)
By providing this treatment [he] interfered in the clinical
management of TU’s condition at the Royal Children's
Hospital; and
(iv)
[He] provided treatment without informing, consulting or
involving TU's treating oncologist.”
The definitions of “unprofessional conduct” contained in section 3(1) of the Act 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
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peers; or
(c)
professional misconduct; or
(d)
infamous conduct in a professional respect; or
(e)
providing a person with health services of a kind that is excessive,
unnecessary or not reasonably required for that person’s well-being;”
Amendment of the Notice
In his written submission Dr Traill stated that he had been denied natural justice because
the Notice had been amended at the end of the five day hearing of evidence and oral
submissions and after witnesses had provided testimony and been cross examined. Dr
Traill said that he had no legal advice about the amendments and was not asked to
agree to the changes. In his submission the changes vitiated the entire hearing and it
should have been aborted and closed.
The Panel had not considered at the time the amendments were made that Dr Traill had
been disadvantaged. However, on receipt of Dr Traill’s written submissions, as an
adjournment had not been called, it determined to hold a further hearing to allow Dr Traill
to make submissions about the amendments and to bring any additional evidence to
address the amendments. At the Panel’s request a letter to that effect was sent to Dr
Traill and the solicitors for the Board.
The written response of Mr O’Neill, Counsel Assisting, was to state that the amendments
were made late in the hearing by reason of the uncertainty as to the precise treatments
administered to the three patients. The correspondence passing between Dr Traill and
the Board used various terms to refer to the treatments and, until the evidence had been
heard, it was not clear which treatments had been given to which patient.
Mr O’Neill further submitted that there was no suggestion in Dr Traill’s submissions that
he had been prejudiced by the amendments or that he would have called for any further
evidence. He also said that, while Dr Traill did not necessarily agree to the amendments
at the time, he did not oppose them. As Dr Traill is not legally qualified and was
unrepresented, the Panel does not take anything from the final point.
Mr O’Neill also referred to the fact that in civil proceedings amendments to pleadings
may be made even after the close of evidence. In particular he referred to the decision in
Loutfi v Czarnikow Ltd1where pleadings were allowed to be amended between the
closing of evidence and before the verdict to deal with facts which had been the subject
of evidence during the trial and the other party had the opportunity to respond.
At the hearing held on 17 October 2005 Dr Traill was given the opportunity to state how
he was prejudiced by the specific amendments to the particulars of the Notice and to
bring any additional evidence. While Dr Traill was asked three times at the hearing if he
wished to comment on the specific amendments, he declined to do so.2 Instead he
made submissions which centred on broad assertions that he had been denied natural
1
2
[1952] All ER 823
Transcript pp.728; 730; 747
8
justice, procedural fairness and due process and so the Panel had broken the law. He
also submitted that how these breaches may prejudice his position or case is immaterial
but obvious. He said the entire conduct of the hearing was influenced by the original
notice and that changing the notice cannot produce retrospectively a document which is
in accord with the earlier hearing. He said “The wish that the Defendant outline what
additional evidence you would have called had the amendments been made earlier is to
enter into an hypothetical phantasmagorical fantasy-land, is quite mischievious and even
more ridiculous. In not accepting its breach and expecting a response the MPB is acting
ultra vires.”3
As the Panel is mindful that Dr Traill is unrepresented it has carefully considered the
submissions made, the nature of the amendments and its understanding of the relevant
legal principles.
The Panel had regard to J R S Forbes’ Justice in Tribunals4 in relation to this matter. In
summary the Panel understands the principles are as follows (with emphasis added):
•
•
•
•
•
•
A notice of hearing such as that in issue here may be amended before a
hearing provided that the amended notice is properly served and enough time is
available to consider any new issues;
A notice may be amended at the hearing and it is said that there is nothing
intrinsically unfair about doing so particularly where it is done to cure a technical
defect;
A notice which is insufficiently detailed at the outset may be “cured” by an
amendment at the hearing;
If the amendment is merely formal, or if it raises nothing that the defendant
cannot reasonably be expected to deal with immediately, or after a short
adjournment, the hearing may proceed with little or no delay;
If there is a significant change of direction, a reasonable time for further
preparation or advice should be allowed. The author says that in such a case the
tribunal would be well advised to suggest an adjournment even if one is not
sought, particularly where the defendant is not represented; and
A court may intervene on natural justice grounds if charges are altered
without due notice. The example given is where a person is charged under one
rule and then, in the light of the evidence which has just emerged, that person is
required to defend himself immediately against a different charge.
The amendments made to the Notice in this case were as follows:
Allegation 1(a):
3
4
(i)
On or about 23 September 2000, you recommended to your
patient a treatment called Hyperthermia, including full body
hyperthermia treatment and partial body, lung hyperthermia
treatment (the’Treatment’), which treatment was not beneficial
or effective for a patient with potentially curable cancer;
(ii)
You failed to provide your patient with adequate information to
obtain her informed consent to the Ttreatment, including your
Dr Traill’s written submission; read intoTranscript pp.729
The Federation Press, Sydney 2002, pages 125-130
9
failure to advise her that her withdrawal from the planned
chemotherapy cycles could adversely effect her health and
prognosis and that the most efficacious treatment for her
cancer was cytoxic chemotherapy and thoracic radiation;
(iii)
You substituted hyperthermia treatment with regional
microwave treatment for your patient without explanation, and
you failed to provide your patient with information about the
potential differences in the outcomes of these different modes
of therapy; provided UHF 434 Mghz microwave therapy
treatment for your patient, which treatment was not beneficial
nor effective for a patient with potentially curable cancer;
(v)
On or about 5 October 2000 until the end of October 2000, you
prescribed lithium to the patient, an experimental treatment,
administered under your knowledge and supervision, by Mr
Spall, that was unnecessary or not reasonably required in the
treatment of your patient;
(x)
You failed to adequately monitor your patient during your
Ttreatment in so far as you monitored the effect of your
Ttreatment by testing the patient's uric acid levels, such
methodology having no support in the small lung cell literature.
Further, until requested by the patient, you did not request CT
scans or undertake adequate x-ray investigation of your
patient;
Allegation 1(b):
(i)
You recommended treatment of her condition with microwave
hyperthermia [words in bold inserted] and local hyperthermia
treatment (the ‘Treatment’);
(ii)
You failed to provide the patient with adequate information to
obtain her informed consent to the Ttreatment;
(iii)
Further, [he] provided her with 15 [words in bold inserted] UHF
434 Mghz regional microwave hyperthermia treatments and
15 local hyperthermia treatments, in circumstances where the
Ttreatment was an ineffective, unproven mode of treatment for
the patient's condition;
(v)
You failed to investigate and diagnose lesions on the skin over
the Ms ST's right breast at the time of providing the Ttreatment
to her;
10
Allegation 1(c)
(i)
You recommended treatment of TU's condition with [words in
bold inserted] UHF 434 Mghz microwave hyperthermia
treatment (the ‘Treatment”) , a form of treatment that has not
been demonstrated to be efficacious for such a condition;
(ii)
By providing this Ttreatment you potentially interfered in the
treating relationship between TU and his parents and Dr Peter
Downie, TU’s treating oncologist;
(iii)
By providing this Ttreatment you interfered in the clinical
management of TU’s condition at the Royal Children's
Hospital; and
(iv)
You provided Ttreatment without informing, consulting or
involving TU's treating oncologist.
While it is correct to say that a variety of terms were used to describe the various
treatments, the Panel is satisfied from its review of the contents of the Book of Evidence
and the transcript of:
(a)
(b)
(c)
Mr O’Neill’s opening and his examination of witnesses;
Dr Traill’s cross examination of witnesses; and
Dr Traill’s evidence in chief and the cross examination by Mr O’Neill
that all parties have understood the hearing to concern the giving of: some form of
hyperthermia and 434 Mghz treatment to Ms SO; some form or forms of hyperthermia
and 434 Mghz treatment to Ms ST; and 434 Mghz treatment to Master TU.
The amendments to the particulars were sought by Mr O’Neill in a part of his cross
examination of Dr Traill where he asked Dr Traill about each allegation and each
particular. The requests for amendments were made while Dr Traill had a copy of the
original notice before him and the process was assisted by his contributions, which
ensured that there was greater clarity and precision in the description(s) of the
treatments. The only objection to the wording made was to the use of the word
“recommended” in particular 1(c)(i) and that word was in the original notice. In relation to
the amendment sought to particular 1(a)(iii), Dr Traill said that he believed that he had
effectively addressed that issue.
While the fact that Dr Traill was engaged in discussions about the use of terminology
and wording does not mean that he is taken to have consented to the eventual
amendments, it does confirm that the amendments concerned identification of a
common and agreed language to describe the treatments.
It is apparent from the Book of Evidence and the transcript that at all times it was
understood by all parties, and the hearing proceeded on the basis that, Ms SO was
given some form of hyperthermia and also 434 Mghz treatment.
As a consequence, the amendment to allegation 1(a)(i) merely removed the reference to
the 434 Mghz treatment and more accurately described the form of hyperthermia.
11
The amendment to allegation 1(a)(iii) amounted to the withdrawal of an allegation. The
words inserted effectively amounted to a separation out of the allegation contained in the
original 1(a)(i) in regard to 434 Mghz treatment.
There was no change to the substance of the original allegation.
The further amendments to the particulars in relation to Ms SO were of an
inconsequential, grammatical nature and did not change the substance of the original
allegations.
Similarly, a review of the Book of Evidence and the transcript shows that at all times it
was known to all parties that Ms ST had been treated with some form or forms of
hyperthermia and 434 Mghz treatment.
The amendment to allegation 1(b)(i) in relation to Ms ST similarly clarified the
terminology and did not change the substance of the allegation. The amendment to
allegation 1(b)(iii) inserted the agreed manner of referring to the 434 Mghz treatment.
The other amendments were also of an inconsequential, grammatical nature and did not
change the substance of the original allegations.
The amendment of allegation 1(c)(i) was to describe the 434 Mghz treatment using the
form of words agreed. It was always the case that all parties understood that was the
only form of treatment Master TU received. The other amendments of the particulars
relating to Master TU were also of an inconsequential, grammatical nature and did not
change the substance of the original allegations.5
While Dr Traill correctly pointed out that the final form of the Notice differed slightly from
the changes which had been discussed at the hearing, those variations were
inconsequential and primarily grammatical.
The Panel is satisfied that the amendments made to particulars 1(a)(i), (ii), (v), (vi), (x), 1
(b)(i), (ii), (iii), (v), and 1(c)(i) to (iv) amounted to the curing of defects of terminology and
so were, in the sense discussed by Forbes, formal. As will be apparent from these
Reasons, the evidence presented and obtained from both parties dealt with the actual
treatments given. It is a matter for the Panel to determine whether the Board has proven
the allegations to the required standard of proof.
Double jeopardy
In his written submission Dr Traill said that particulars 1(a)(v) and (vi) ought to be
dismissed because they are the subject of double jeopardy. Those particulars concern
the use of lithium.
Mr O’Neill provided submissions in response which said in summary:
5
Generally Transcript 3-11; 18-20; 483-484; 428 ff; 519-540; 542-547; 553-556; 607; 614; 649-662; 670671; Book of Evidence Tabs 11, 27 and 29; Transcript pp.670-672 re Ms SO; 695-670 re Ms ST and Master
TU
12
•
•
•
•
The Health Insurance Commission (“HIC”) held a hearing under the Health
Insurance Act 1973 (Cth) into Dr Traill’s prescribing of lithium over the period 6
July 1995 to 9 November 1995. In 1997 a referral under that Act was made to
the Board;
An informal hearing into Dr Traill’s prescribing of lithium was held on 18
December 1997. The Panel constituted to hear that matter found that Dr Traill
had not engaged in unprofessional conduct;
The record of that Panel’s decision indicates that matters relevant to the finding
included the fact that Dr Traill had obtained the informed consent to the
administration of lithium to the patients in question and he carefully monitored the
patients. In addition, that Panel had regard to the fact that Dr Traill had told the
Board that he no longer used lithium for the treatment of cancer patients and only
infrequently used it for patients with multiple sclerosis. That Panel expressed
“grave concerns about the nature of the treatment ie. That he engages in a range
of unconventional practice and uses unorthodox treatments”;
A further referral was made to the Board by the HIC in 2002 and a formal hearing
was held on 29 March 2004. The subject of that formal hearing did not include
the prescription of lithium to patients during the period dealt with in the December
1997 informal hearing.
Dr Traill submitted that the prescribing of lithium for non-psychiatric uses had been
examined by the Board and dismissed. Because he obtained the informed consent of
patients in this present case, he said the particulars should be dismissed. He also said
the comment about him not using lithium to treat cancer was true because he was not
treating cancer patients at that time.6 He further submitted that the question of the use
of lithium had been expressly deleted from the Notice for the 2004 formal hearing by the
solicitors for the Board on the basis of double jeopardy and the same should have been
done here. He said its inclusion in the Notice before this Panel “is a deception”.7
Mr O’Neill submitted that Dr Traill could not be said to be subject to double jeopardy in
relation to particulars 1(a)(v) and (vi) because those particulars concerned different
patients and facts. He said that the only basis on which Dr Traill could raise the informal
hearing finding was to the extent that, arguably, a finding by this Panel that the
prescribing of lithium could amount to unprofessional conduct would be inconsistent with
the earlier finding of no unprofessional conduct. Given the terms of the informal hearing
Panel’s decision, it was said that there would be no inconsistency in this Panel reaching
a contrary view in relation to the prescribing for Ms SO.
It is correct to say that it would not be open to the Board to refer particulars to a Panel
whether for an informal or formal hearing where those same particulars had already
been the subject of a decision by another Panel. However, in this case the particulars
are not the same as those which were considered by the December 1997 Panel. The
particulars before this Panel arose during a different period of time and relate specifically
to the appropriateness of the prescribing and monitoring of lithium in relation to one
patient.
As this Panel understands it the finding of the December 1997 Panel was based on its
assessment of what Dr Traill said about his consent and monitoring procedures and also
6
7
Transcript pp. 738
Transcript pp.735
13
on certain statements he gave about his then current use of lithium for cancer patients.
The finding was based on the material before it and the particular facts. It cannot be
read to mean that the Panel concluded that all future prescribing of lithium would be
appropriate. The fact that the Panel took into account Dr Traill’s statement that he had
stopped prescribing lithium for cancer patients seems most pertinent.
In any event, decisions of other Panels constituted by the Board are not in any sense
binding authority on the findings of this Panel, particularly where the facts differ.
The Panel considered particulars 1(a)(v) and (iv) were able to be heard.
Dr Traill
A written Curriculum Vitae was provided by Dr Traill.8 In summary, he obtained a MB BS
and FRCPA. For the purposes of the HIC, he is categorised as a Specialist Pathologist
Consultant and is a vocationally registered general practitioner. He described himself as
“involved in General Practice since 1989, with subsequent extensive experience”. He
described his background as including experience in pathology – morbid anatomy,
histology, clinical chemistry, immunology, serology, microbiology and including autopsy
reports for the Coroner and private pathology work.
He said he had assisted Dr Roy Bean in his oncology practice until 1990, acted as Dr
Bean’s locum tenens, and assumed therapy for some of his patients after Dr Bean died
in 1990. He stated that he had “published/read” some 56 papers on diverse topics and
has an Amateur Wireless Licence.
Dr Traill was employed at the OncoCare Cancer and Prostcare Clinic at Fairfield
(“OncoCare Clinic”) from April 2000 until it closed in 2003.
The treatments
It is appropriate to describe the relevant treatments referred to in the Notice in some
detail. More will be said in relation to each in the context of the particular allegations
later.
Hyperthermia treatment
Hyperthermia has been used for almost 100 years in the treatment of cancer alone or in
conjunction with radiotherapy and/or chemotherapy. In the context of cancer treatment,
hyperthermia is described as a means of the controlled heating of cancerous tissues to
temperatures that kill the cells. It is generally understood that in order to be effective the
tumour being treated would need to be heated to between 41°C and 45°C. The
effectiveness of the treatment depends upon the temperature distribution within the
tumour and the duration of the heating. Accordingly, detailed thermometry is required.
The thermometry may be achieved via implanted temperature sensors or, in appropriate
cases, surface sensors. The heating is achieved via the use of ultrasound for superficial
tumours and microwaves for deep seated tumours.9
8
Book of Evidence, Tab 28 and Exhibit 5
Book of Evidence, Report of Dr L J Peters, Tab 106(a), Position Statement on Radiotherapy/Hyperthermia,
Tab 103 – at the time the Position Statement was drafted Professor Peters was the Dean of the Faculty of
9
14
A 2003 position statement produced by the Quality Committee, Faculty of Radiation
Oncology of the Australia and New Zealand College of Radiologists10 says that the
principal role of hyperthermia in contemporary radiation oncology is adjuvant (assisting
treatment). Where local radiotherapy for an advanced tumour produced poor local
control alone, it may be assisted by hyperthermia to produce a net overall cure rate and
survival. Hyperthermia can also provide more effective palliation particularly in recurrent
tumours.
The statement expressed the view that hyperthermia combined with
radiotherapy was of proven clinical benefit for pelvic malignancies, chest wall breast
cancer recurrences and definitive treatment of metastatic/recurrent melanoma.
Treatments outside these areas were regarded as investigational and some of the areas
expressly referred to in the context of this case were head and neck and advanced
breast cancers.
Professor Lester Peters, Professor of Radiation Oncology at the Peter MacCallum
Cancer Centre and the Chairman of the Peter MacCallum Cancer Foundation, gave
evidence that, in his experience, on the rare occasions hyperthermia has been given it
has been combined with chemotherapy. He said that he was unaware of beneficial
results arising from whole body hyperthermia alone, other than anecdotal reports from
the turn of the 20th century.11 Dr Traill’s submission stated that whole body hyperthermia
on its own had a limited value but was not useless.
It appears to be indisputable that, although significant benefits can result from combined
hyperthermia and radiotherapy or chemotherapy, there are practical limitations on the
delivery of the treatment which mean that it is not widely available. The practical
limitations include the difficulty of ensuring that the temperature delivered to the tumour
reaches 41°C and does not exceed 46°C. Evidence was given that temperatures below
41°C may result in the stimulation of tumour growth12 and temperatures in excess of
46°C may lead to significant pain and patient discomfort, acute tissue damage and the
capacity of major organs to tolerate relatively brief exposures to temperatures of around
41.5°C .13 Professor Peters gave evidence to the effect that the significance of
thermometry had been a recurring theme in the discussions of hyperthermia since the
1980’s and difficulties associated with it was the “Achilles heel . . . of widespread
application of hyperthermia.”14
The position statement referred to above sets out suggested requirements for the
effective and safe administration of hyperthermia which included the following matters:
•
•
The combination of radiotherapy and hyperthermia should be administered in
a multi-disciplinary context in the setting of a level 5/6 tertiary referral oncology
hospital;
The need for comprehensive, appropriately qualified medical engineer
support with experience in ultrasound, microwave, EMF generation and
thermometry;
Radiation Oncology of the Royal Australian and New Zealand College of Radiologists and approved the
document – see Transcript pp. 105
10
Book of Evidence, Tab 103
11
Transcript pp. 113
12
Dr Peters’ report, Book of Evidence, Tab 106(a)
13
Statement of Position, Book of Evidence, Tab 103; Dr Peters’ report, Book of Evidence, Tab 106(a)
14
Transcript pp.420, 108
15
•
•
•
•
•
A properly constituted hospital based radiation safety committee;
A senior radiation oncologist with experience in hyperthermia administration;
Written departmental protocols for treatment;
A clinical team of radiation oncologists, radiation therapists and nursing staff
with regular documented CPD and competency assessment; and
A comprehensive quality assurance programme.
Hyperthermia treatment may be given in three forms: full body using what is known as a
Heckel tent; regional (such as for the treatment of prostate cancer); and local, here
directed at an area of skin.
434 Mghz treatment
In his submission to the Panel, Dr Traill said that the details of the 434 Mghz treatment
were to be found in his submission to the National Health and Medical Research Council
Review of Microwave Cancer Therapy (“NHMRC Review”). In summary, it is understood
by the Panel that in that submission Dr Traill:
•
•
•
•
•
•
•
Explains he became interested in 434 Mghz treatment as a result of his interest
in lipoprotein biochemistry, the non-psychiatric uses of Lithium and his long
standing amateur wireless licence;
States that in early 2000 he acquired the required machines and commenced
applying them to patients apparently at the OncoCare Clinic;
States he has made observations about the work of Dr John Holt in Perth who is
said to have discovered the effect of 434 Mghz on cancer. Some of those
observations have included disagreeing with some of what Dr Holt has said and
theorised. From time to time in the submission he states that he cannot follow
certain points made by Dr Holt;
Explains that in establishing 434 Mghz as a treatment for cancer, Dr Holt has
emphasised three points, which appear to be accepted by Dr Traill. Those points
are as follows:
o
434 Mghz power is absorbed over cancers which is evidenced by
changes in plate output current on transmitters and/or core temperature
rises in patients;
o
A “fascinating resonance phenomenon”, seen by Dr Traill only in the
form of photos taken by Dr Holt, occurs when 434 Mghz is applied to
cancerous tissue. It is said that when 434 Mghz is applied to that tissue
there are short term “bursts” of frequencies emitted both below and above
the 434 Mghz frequency. It is said that “This can only be explained by
energy being supplied by the living cancer tissue . ..”; and
o
The clinical observations made by Dr Holt over time. It is noted that
the observations have not been able to be compared to a control group as
that has not been possible to establish;
Discusses the “glucose blocker” substance used by himself and Dr Holt. This will
be discussed in more detail later;
Refers to studies undertaken by Caldwell and Hornback which will be referred to
later;
Says “we are then left with two options – either the resonance phenomenon and
all the work related to it has a real basis or else it is all an extended aberration.
In favouring the former, recognising the near impossibility of establishing control
16
•
•
•
•
•
groups, and with the likelihood of flak, I set out to seek surrogate evidence that
434 Mghz with the Holt protocol had effects we may regard as desirable, and to
be obtained as quickly as possible”;
He sets out his own clinical experience which he describes himself as “limited”.
Details of particular treatments for patients are provided in addition to various
results and graphs;
Presents what he described as a “Unifying Hypothesis”. He says that, from the
photographs and documented background relating to the resonance emission,
there can be little doubt that:
“a)
Energy is produced within the tumour to augment the incident emission,
b)
This energy requires living tissue,
c)
The central frequency is relatively stable (tumour to tumour) but with brief,
intermittent, close variations of the resonance frequency to the incident
frequency during each exposure throughout the tumour populations, and
d)
The pattern is sensitive to biochemical agents administered
intravenously.”
Explains that he believes that the part of the cell which is capable of being a
resonator of 434 Mghz is the centriole within the cancer cells;
Discusses blood levels he monitored for some patients and particular changes in
the calcium to urate ratio after 434 Mghz treatment. He then says: “Based upon
these very preliminary results, which seem consistent with the 434MHz +/‘glucose blocker’ having some measurable effect, there appears some potential
in following such changes with a larger series and in a more detailed way”; and
After discussing a patient who had leiomyosarcoma of the uterus and her after
treatment results which he says show changes in the cells he says: “Such
changes in isolation have limited meaning, given the possible variations within
tumours and the problems of fixation and processing. However, the general
pattern is consistent with the changes reported by Holt.”
Dr Traill also referred the Panel to articles published by Dr Holt. Dr Traill’s submission to
the NHMRC Review includes reference to studies in 1977 and 1979 by Hornback’s
group which involved a combination of 434 Mghz treatment and also radiotherapy. Dr
Traill also referred to work by H Fröhlich which he regarded as supporting the use of 434
Mghz treatment.
Taking the submission together with the various photographs taken by Dr Holt, it
appears, in admittedly very simple terms, that the theory is that when 434 Mghz
treatment is applied to cancerous tissue there is a greater resonance than for healthy
tissue. Where that treatment has been given over a period of time with the ‘glucose
blocker’, the resonance pattern becomes more consistent with that for healthy tissue and
that indicates that the treatment has in some way broken down the cancerous tissue or
changed it.
At the hearing Dr Traill said that, to his knowledge, other than himself, the only persons
in the world offering 434 Mghz treatment are Dr Holt and a clinic in Northern Ireland
which he believed may have been related to Dr Holt in some way.15
Lithium
15
Transcript pp. 607-608
17
The submission made by Dr Traill to the NHMRC Review included some material
regarding lithium. The relevant section indicates that Dr Traill has prescribed lithium for
a number of conditions including multiple sclerosis and rheumatoid arthritis. Attached to
his written submission to the Panel was a copy of a document written by Dr Traill which
he described as notes for patients and it is understood that document was given to Ms
SO, Ms ST and Master TU’s parents. The document says in part:
“Lithium is a metallic element which forms salts. Such salts were used in the
18th century as a treatment of gout (not recommended now).
More recently the salts are known to have many effects which can be utilized in
certain circumstances, for example it: 1/ Stimulates the bone marrow to produce more of the white cells which fight
bacteria,
2/ Unblocks the immune system (eg by blocking suppressor cell activity and
increasing Interlukin 2 production),
3/ Reduces the level of the hormone which stimulates acid production in the
stomach,
4/ Reduces agitation and excitement in those who are mentally overactive
(having almost no effect on normal people). It may reduce the incidence of
some mental depression,
5/ Blocks the hormone which makes your kidneys retain fluid.
The Point of Action for Lithium appears to be largely at the surface of the tissue
cells, where it blocks incoming passengers from switching on certain key cell
activities; but other things happen. Lithium stimulates certain cells, such as
monocytes and lymphocytes, to produce Tumour Necrosis Factor (‘TNF’) –
necrosis means ‘cell-killing’. . . . Under the right circumstances: a) TNF can be toxic to abnormal cells such as tumour cells and those with
viruses
b) TNF activates cellular attacks by killer immune cells upon cancer cells.
c) TNF has an antiviral effect protecting cells from viral attack . . .
d) TNF stimulates the production of Granulocyte/monocyte Colony Stimulating
Factor (‘GM-CSF’) a very close relative of G-CSF. The latter is now being
marketed (at great cost) to stimulate the bone-marrow after immunesuppressive drugs (the trade name is Neupogen). It is GM-CSF which
stimulates the white blood cell rise after the start of Lithium therapy and
probably indicates that TNF has been made.
e) The combination of TNF and Lithium can be more powerful in certain
circumstances, with Lithium ‘priming’ the cell surface receptors.
f) TNF appears to upset the blood supply to larger tumours at least.
...
Experience in Clinical Practice indicates that, whilst Lithium can stimulate TNF
etc., it can also block effectiveness whilst it is present. It is by the
asynchronous actions of Lithium, TNF, GM-CSF and other factors in the rise
and fall of their activities that the potential effectiveness of Lithium as a cancer
treatment is manifest.” (Dr Traill’s emphasis)
18
It must be noted that the notes for patients discussed above were not provided before or
during the hearing and so they were not available for review by the witnesses called by
the Board.
Dr Traill also attached to his written submission a copy of an article entitled “The Use of
Lithium Carbonate to Reduce Infection and Leukopenia During Systemic
Chemotherapy”.16 He also provided an abstract from an article consistent with his use of
lithium and another abstract in relation to its use for patients with persistent neutropenia
following chemotherapy and radiotherapy.17
The Patients
Ms SO
Ms SO was born on 21 April 1956 and was the mother of a daughter. In
August/September 2000 when she was 44 years old and living in South Gippsland, Ms
SO was diagnosed with small cell carcinoma of the lung.
She commenced
chemotherapy treatment under the care of Dr John Scarlett and completed three cycles
of treatment. Ms SO had difficulty coping with the chemotherapy and made enquiries
about an alternative form of treatment which led her to the OncoCare Clinic.
On 4 October 2000 Dr Scarlett wrote a letter regarding Ms SO’s then condition which it
was understood was to be used to apply for the early release of superannuation funds.
In that letter Dr Scarlett said that Ms SO’s disease carried an average lifespan of 8 to 12
months with standard treatment being intravenous chemotherapy and possibly
radiotherapy to the chest and brain. Dr Scarlett stated that without treatment her survival
would be expected to be no more than three months.
Ms SO had a consultation with Dr Traill on 28 September 2000 and commenced
treatment at the OncoCare Clinic on 6 October 2000. The treatments, which will be
discussed later, concluded on 2 November 2000.
In December 2000 Ms SO contracted pneumonia and was admitted to what was then the
Leongatha Memorial Hospital. Her then general practitioner arranged for an X-ray and
CT Scan to be carried out. The results showed there to be a large mass which was
measured at 15 cm. Ms SO was discharged from hospital on 11 December 2000 and
commenced treatment at the Peter MacCallam Cancer Institute on 25 January 2001.
During the period January 2001 to August 2002 Ms SO was treated with chemotherapy
and radiation therapy. Ms SO tolerated the chemotherapy well. Over this period she
was admitted to the hospital seven times and one of the nodes reduced in size from 15
cm to 2 cm. However, in April 2002 it was determined that her disease had progressed
to a point at which palliative treatment was appropriate.
Ms SO lodged a complaint about the treatment given by Dr Traill with the Office of the
Health Services Commissioner on 20 February 2001 which was referred to the Board.
On 7 November 2001 Ms SO was interviewed by Dr Sally Middleton, an investigator
16
Gary H Lyman, Charles C Williams and Dennis Preston, The New England Journal of Medicine, (January
31, 1980), Vol 302 No 5
17
Exhibit 4
19
employed by the Board about her complaint and treatment. Ms SO died on 31 August
2002 before an affidavit could be finalised and sworn by her.18
Ms ST
Ms ST was born on 22 March 1954 and at all relevant times has lived in Tasmania. She
has a teenage son. In December 1996 she was diagnosed with breast cancer and
commenced chemotherapy in January 1997. A lumpectomy operation was conducted in
April 1997 after which Ms ST had further treatment with chemotherapy and radiation
therapy until June 1997. During the period July 1997 to 2000 Ms ST had regular
ultrasound and mammograms. In 2000 it became apparent that there had been a
recurrence of the disease and Ms ST had further surgery on 30 November 2000.
Further chemotherapy had been recommended by Ms ST’s oncologist.
Ms ST had read about hyperthermia treatment and sought referral by her general
practitioner to the OncoCare Clinic requesting assessment for radiowave hyperthermia
treatment.
Ms ST had her first consultation with Dr Traill on 22 December 2000 with a further
consultation apparently held on 22 January 2001. Her treatment at the OncoCare Clinic
commenced on 22 January 2001 and continued until 9 February 2001.
During her treatment, Ms ST was aware of a skin lesion located approximately seven cm
below the incision line from the November 2000 surgery. Ms ST’s discussions about the
lesion with Dr Traill will be dealt with later. On her return to Tasmania, Ms ST attended
her surgeon, who on 9 March 2001 conducted a biopsy which found that the lesion was
cutaneous adenocarcinoma. In March 2001 Ms ST had a radical mastectomy and
commenced chemotherapy treatment. In April 2001 Ms ST travelled to the St George
Hospital Center for Internal Medicine, Oncology, Hematology, Immunology &
Environmental Medicine in Germany for additional treatment. Between April and May
2001 she had treatment in Germany which included whole body hyperthermia under a
general anaesthetic and local hyperthermia and chemotherapy. On her return from
Germany Ms ST continued treatment from time to time as advised by her specialist
medical practitioners. Unfortunately her disease has continued to recur. Ms ST gave
evidence before the Panel.19
Master TU
Master TU was born on 18 March 1996 and lived in Gippsland with his parents and, at
that time, his two siblings. In July 2001 Master TU was diagnosed with an anaplastic
ependymoma. The tumour was described as a primary malignant neoplasm of the brain
arising from the cells that line the ventricles of the brain and as an aggressive form of
cancer which in the case of Master TU was untreatable.20
He was referred to Dr Peter Downie at the Royal Children’s Hospital (“RCH”). Master
TU was also examined by Dr DD of the RCH. Dr Downie met with Master TU’s parents
18
Book of Evidence Tabs 6, 9, 15 & 18, Ms SO’s medical records
Affidavit of Ms ST sworn 25 November 2004, Book of Evidence Tabs 41,43 and 45 and Ms ST’s medical
records
20
Professor Peters’ evidence Transcript 114
19
20
and it was agreed after lengthy discussion that palliative chemotherapy and radiotherapy
treatments would be given. A central line was inserted to allow the chemotherapy to be
administered, however that treatment did not proceed. Instead, Master TU’s parents
took him to Sydney to have surgery at The Prince of Wales and Sydney Childrens’
Hospital on 21 July 2001. It was apparently hoped that the surgery would remove the
tumour and satellites. On their return from Sydney, Master TU’s parents met again with
Dr Downie who arranged for a scan to be conducted. The scan showed that the tumour
had not been removed. The medical records indicate that it was intended as at August
2001 for Master TU to be reviewed further and a palliative treatment plan was to be
prepared. Part of the review was to include MRI Scan of the head and spine in mid
August.21
In a handwritten note22 Master TU’s parents said that they heard about Dr Traill from
another cancer patient and were otherwise considering going to Perth to see Dr Holt.
Master TU died on 1 December 2001.
Dr DD made a complaint to the Board about the treatment of Master TU in a letter dated
11 April 2002.23
21
Affidavit of Dr P Downie affirmed 19 April 2005, Book of Evidence Tab 99, Master TU’s medical records
Book of Evidence, Tab 116
23
Book of Evidence, Tab 70
22
21
Preliminary matters
Admissibility of hearsay evidence and basis for findings of fact
During the hearing Dr Traill commented to witnesses from time to time that what they
said in their reports or in their evidence was hearsay.
Section 52(1)(c) of the Act states that a panel appointed under the Act is “not bound by
the rules of evidence but may inform itself in any way it thinks fit.” Section 52(1)(d)
states that a panel is bound by the rules of natural justice.
The case law and legal commentary makes it clear that a panel such as this may have
regard to hearsay evidence. It is understood that the fact that the evidence is of a
hearsay nature may affect the weight the Panel would be prepared to give to it. In order
to rely on hearsay evidence to make a finding of fact, it is necessary for that evidence to
have some probative value. The weight to be given to hearsay evidence is a matter for
the Panel. Brennan J in Re Pochi and Minister for Immigration and Ethnic Affairs said
relevantly:
“. . . hearsay ‘has a wide scale of reliability’ . . . and there is no reason why
logically probative hearsay should not be given credence. However, the logical
weaknesses of hearsay may make it too insubstantial, in some cases, to
persuade the tribunal of the truth of serious allegations.”24
The onus of proof in matters such as this falls on the Board and the standard of proof to
be met is that discussed in Briginshaw v Briginshaw25:
“The truth is that, when the law requires the proof of any fact, the tribunal must
feel an actual persuasion of its occurrence or existence before it can be found.
It cannot be found as a result of a mere mechanical comparison of probabilities
independently of any belief in its reality. No doubt an opinion that a state of
facts exists may be held according to indefinite gradations of certainty; and this
has led to attempts to define exactly the certainty required by the law for
various purposes . . . Except upon criminal issues to be proved by the
prosecution, it is enough that the affirmative of an allegation is made out to the
reasonable satisfaction of the tribunal. But reasonable satisfaction is not a state
of mind that is attained or established independently of the nature and
consequence of the fact or facts to be proved. The seriousness of an allegation
made, the inherent unlikelihood of an occurrence of a given description, or the
gravity of the consequences flowing from a particular finding are considerations
which must affect the answer to the question whether the issue has been
proved to the reasonable satisfaction of the tribunal. In such matters
‘reasonable satisfaction’ should not be produced by inexact proofs, indefinite
testimony, or indirect inferences.”
24
(1979) 26 ALR 247 at 256-257; See also Justice in Tribunals JRS Forbes, The Federation Press, 2002,
paragraphs [12.63] to [12.64]
25
(1938) 60 CLR 336 at 361-362 per Dixon J
22
Admissibility of information from Ms SO
As Ms SO passed away before her evidence could be recorded in the form of an
affidavit, there was no sworn evidence available to the Panel from her as to the
allegations or any opportunity for Dr Traill to cross examine on that evidence. Instead,
the Book of Evidence contained Ms SO’s letter of complaint to the Office of the Health
Services Commissioner, a diary note of an interview held with Ms SO by a Board
investigator which included hand written amendments and notations apparently made by
Ms SO, and a letter addressed to the Deputy Chief Executive Officer of the Board which
commented on Dr Traill’s response to the notification.26
It was submitted by Mr O’Neill that the Panel was entitled to have regard to the
information available from Ms SO. While confirming that the Panel is not bound by the
rules of evidence he made reference to section 55 of the Evidence Act 1958 (Vic) which
states relevantly:
“(1) In any legal proceeding (not being a criminal proceeding) where direct oral
evidence of a fact would be admissible, any statement contained in a document
and tending to establish that fact shall be admissible as evidence of that fact if(a)
the maker of the statement had at the time of the making of the
statement personal knowledge of the matters dealt with by the
statement, and is called as a witness in the proceeding;
...
(5) Notwithstanding anything to the contrary in the foregoing provisions of this
section, the condition that the maker of the statement or the person who
supplied the information, as the case may be, be called as a witness need not
be satisfied where(a)
he is dead, or unfit by reason of his bodily or mental condition to
attend or testify as a witness;”
In his submission Mr O’Neil said the Panel was entitled to have regard in particular to the
statement signed by Ms SO and that it was then a matter for it what weight the content of
the statement should be given.
The Panel accepts those submissions as correct.
Dr Middleton, the Board investigator, swore an affidavit27 and gave evidence before the
Panel about the investigation she conducted, the interview she held with Ms SO and her
diary note. In that evidence Dr Middleton said that she was given material about the
notification and commenced collecting information. She made contact with Dr GG about
a letter he had written to the Board regarding Ms SO’s treatment. A diary note was
made recording her discussion with Dr GG.28 She then said that she had interviewed Ms
SO at Ms SO’s home on 7 November 2001 and that the interview was informal with her
26
Book of Evidence, Tabs, 6, 9 & 10
Book of Evidence, Tab 100A
28
Book of Evidence, Tab 8
27
23
recording the discussion in longhand notes. She said that the way she gathered
information was to ask open ended questions and to allow the person being interviewed
to tell her what they wished and follow up on relevant points. While Dr Middleton agreed
with Dr Traill that the matters raised by Dr GG gave her leads to questions, she stated
that her interview technique was not influenced by Dr GG’s letter or comments to her.
Dr Traill took Dr Middleton through the detail of her diary note to ask questions about any
further knowledge Dr Middleton had, and what she understood from the comments made
by Ms SO. Dr Middleton’s clear evidence was that the diary note was a record of what
she was told by Ms SO, and did not contain her own comments or reflections on what
was said. In relation to the hyperthermia treatment, Dr Middleton’s evidence was that
she had no prior understanding of the treatment and that what she had written about the
treatment was what Ms SO told her and that “the understanding [of] the treatment is hers
completely.” Similar evidence was given in relation to the references in the notes to
lithium and the equipment used at the clinic.
Dr Middleton said that her practice was to type up notes of telephone conversations,
such as that held with Dr GG, and interviews as soon thereafter as possible. In the case
of the interview with Ms SO, this was done on her return to the Board’s offices and so
she regarded the typed record of the notes as contemporaneous.29
Dr Middleton’s evidence was that her best recollection was that the handwritten notes
made on a copy of the diary note were made by Ms SO.
The Panel accepted Dr Middleton’s evidence, in particular the evidence to the effect that
the diary note comprised her record of what was said to her by Ms SO in the interview,
and recorded Ms SO’s understanding and description of events.
At the conclusion of Dr Middleton’s evidence, from the bar table Mr O’Neill gave an
explanation about the attempts made to arrange for an affidavit to be sworn by Ms SO.
Mr O’Neill suggested that an affidavit could be sworn by his instructing solicitor, Ms Jane
Salveson, dealing with those matters. Dr Traill initially expressed the view that there was
no need for an affidavit to be sworn. When the Panel asked whether he understood that
it would rely on what Mr O’Neill had said as correct, Dr Traill said that he would prefer an
affidavit to be sworn. Mr O’Neill suggested that instead, it would be preferable for Ms
Salveson to give evidence before the Panel.
Ms Salveson’s evidence was brief and was to the effect that, while an affidavit was
prepared for swearing in July 2002 and delivered to Ms SO, Ms SO was too unwell to do
so.
Medical Records
At the hearing Dr Traill said that he believed that either the Board’s solicitors had failed
to provide him with all medical records they held, or that the relevant doctors, clinics or
hospitals had not provided complete records.30 These concerns were also raised in Dr
Traill’s written submissions.
29
30
Transcript pp. 159-178
Transcript pp. 288; 361; 441-447
24
Mr O’Neill confirmed to the Panel that medical records relevant to the patients had either
been provided under authority from the patient or subpoenaed. The Panel was told that
other than early file notes regarding Ms ST, all records had been provided to the Board’s
solicitors and to Dr Traill. In relation to the early notes for Ms ST relating to her
consultations with Dr Scarlett, while Mr O’Neill and the solicitors for the Board
considered them to be irrelevant, it was agreed that the records for a specified period
would be sought and provided to Dr Traill. What records that existed were provided.
The Panel indicated to Dr Traill that, if he wished to argue that the notes provided were
incomplete or that some had been withheld, it was necessary for him to provide some
evidence to that effect. Otherwise, the effect of his position was to suggest that the
recipients of subpoenas had failed to comply and so had committed an offence under
section 53 of the Act and under section 16 of the Evidence Act 1958 (Vic).
No such evidence was produced.
NHMRC Review
In September 2004 the Commonwealth Minister for Health and Ageing, the Honourable
Tony Abbott, MP requested that the National Health and Medical Research Council
(“NHMRC”) undertake a review of the therapeutic effectiveness and safety of microwave
(UHF) cancer therapy.
According to the NHMRC website it:
“…established the Review Committee on Microwave Cancer Therapy (UHF
Radiowave in the range 300 MHz to 300 GHz) which was required to, having regard
to the best available evidence and following consultation with relevant individuals
and organisations:
1. Establish and describe the scientific basis of microwave (UHF radiowave)
therapy in the treatment of cancer;
2. Assess the effectiveness and safety of microwave (UHF radiowave) cancer
treatments, including the use of the Tronado machine; and
3. Identify gaps in research knowledge.”31
On 29 September 2005 the Commonwealth Government released the Review
Committee’s report. A press release issued that day by the Minister included the
following:
“The review committee found no scientific evidence to support the use of
microwaves in treating cancer, either alone or when combined with other
therapies.
31
www.nhmrc.gov.au/advice/consumers/microwave.htm
25
The final report on the therapeutic effectiveness and safety of microwave cancer
therapy concluded that:
•
•
•
•
•
•
•
There is no high-quality published scientific evidence which shows
superior benefit in terms of therapeutic effectiveness for the treatment of
cancer with:
o microwave (or UHF) cancer therapy when combined with
radiotherapy (used by Dr Holt before 1991); or
o microwave cancer therapy when used in combination with glucose
blocking agents (used by Dr Holt since 1991)
Microwave cancer therapy in combination with radiotherapy was inferior
compared to standard conventional radiotherapy with respect to disease
control and survival for patients with breast cancer, lung cancer,
lymphoma or prostate cancer.
There was no significant difference in survival between conventional
radiotherapy and microwave therapy used in combination with
radiotherapy for patients with head and neck, colorectal or bladder
cancer.
Microwave therapy in combination with glucose blocking agents was
inferior to radiotherapy in terms of symptom control and disease control in
patients with bladder or any invasive cancer.
There is insufficient information to make a reliable assessment of the
safety of UHF in combination with radiotherapy, or in combination with
glucose blocking agents for the treatment of patients with cancer.
Conventional radiotherapy had better symptom control rates in bladder
cancer patients, than UHF in combination with radiotherapy or in
combination with glucose blocking agents.
UHF in combination with glucose blocking agents appeared to have a
lower rate of toxicity than UHF in combination with radiotherapy, or
conventional radiotherapy.
It is important that every effort is made to ensure cancer patients continue to
have access to proven effective cancer therapies.
It is important that patients have access to accurate information about benefits
and risks of treatment for cancer and other diseases so they can make fully
informed decisions.
The committee was made up of eight scientists, specialists and clinicians and a
consumer representative, who worked on this review for almost a year.”32
During his opening address Mr O’Neill submitted that the Panel ought not wait for the
results of the review which was then still underway. He said at that time enquiries made
of the Minister’s office indicated that the report would not necessarily be released to the
public.33 In his initial written submission Mr O’Neill noted that the charges brought
against Dr Traill were distinct from the terms of reference, it was not known whether the
form of treatment being examined was the same as that offered by Dr Traill, and Dr Traill
32
33
http://www.nhmrc.gov.au/news/media/rel05/holt.htm
Transcript pp.61-62
26
himself has said there were differences between his treatments and those of Dr Holt. He
submitted at that time and after the report was published, and before the Panel gave its
decision that, because the nature of the enquiry by the NHMRC and that of the Panel
were so different, the Panel ought to proceed to determine the allegations without regard
to the findings of the NHMRC Committee.34
Dr Traill himself expressed reservations about the NHMRC enquiry both while it was
being held and after its report was issued. In his written submission he said that, while
he had made a submission to the enquiry, it had not included references to work by Mr H
Fröhlich, and so “the conclusions of the enquiry may lack a theoretical, scientific basis
and be limited.”
In his submission provided after the report was published Dr Traill said that, despite a
number of flaws in the review, it did confirm that the 434 Mghz treatment does have an
effect that may be beneficial in certain cancer patients. He listed what he regarded as
deficiencies in the report, including the fact that the review missed the work of Mr
Fröhlich, did not consider the role of the centriole and was largely concerned with a
comparison of radiotherapy alone or with 434 Mghz rather than considering 434 Mghz
when given alone.
The role of the Panel is not to undertake an enquiry of the type which was undertaken by
the NHMRC. The Panel’s role is to hear and determine the matter before it (see s. 49(a)
of the Act). In order to complete that task the Panel must primarily rely upon the
evidence before it and decide whether or not the allegations are made out.
Taking into account the fact that the enquiry appears not to have dealt with the manner
in which Dr Traill gave the 434 Mghz treatment and given his own stated concerns about
its relevance to his practices, the Panel has not taken into account the findings made or
views expressed in the NHMRC Report.
34
Transcript p.746; written submissions
27
Evidence
Expert evidence and witnesses
The Panel heard evidence from three of the notifiers, Ms ST, Dr DD from the RCH and
Dr GG from the Peter McCallum Clinic.
In addition, a number of experts were called by the Board to give evidence about the
particular treatment of the patients and also more general evidence about treatments for
cancer patients. Those experts and their qualifications are as follows:
Professor Lester Peters – Radiation Oncologist, Peter McCallum Clinic
Dr Roslyn Drummond – Radiation Oncologist, Peter McCallum Clinic
Dr DD – Radiation Oncologist, Peter McCallum Clinic
Dr Peter Downie - Pediatric Hematologist and Oncologist, RCH
A written report from Dr Gail Ryan for the Board was also before the Panel. A written
report from Professor Richard Fox, Director, Department of Clinical Hematology and
Medical Oncology, The Royal Melbourne Hospital was provided on behalf of Dr Traill.35
Dr Traill gave evidence and he also called his former nurse, Ms Robyn Folan.
Dr Traill’s submissions as to evidence and witnesses
In his written submission Dr Traill said that none of the experts who gave evidence to the
Panel were his peers and that his only peer is Dr Holt. He said that none of the experts
were Fellows of the Royal College of Pathologists of Australasia, none were categorised
as Specialist Consulting Pathologists or similar, none were conversant with the chemical
pathology or the biophysical principles involved, and none were experts in relation to the
treatments or the use of radio frequency, non ionising irradiation and its effects on
tissues.
The Panel notes that the allegations contained in the Notice did not concern the practice
of pathology but rather the treatment of cancer.
In Dr Traill’s view the experts called by the Board were involved in a turf war, were
prejudiced and bigoted with respect to the use of the title “Oncologist”. He warned that
the Board, and presumably the Panel, should beware the “temptation to become an
adjudicator in ‘exclusive club’ disputes.”
In his written submission Dr Traill detailed various bases on which he considered the
evidence given by each of Professor Peters, Dr GG, Dr Drummond, Dr Downie and Dr
Ryan was to varying degrees tainted by bias, a lack of experience in relevant areas and
so ought to be discounted. He was also extremely critical of the conduct of the solicitors
for the Board and Counsel Assisting. Dr Traill asked a number of these witnesses if they
had been paid to make complaints and/or appear before the Panel.
Further, Dr Traill suggested that Ms SO may have been cognitively impaired because of
the treatments she had undergone and that she “may also have presented as a toxic,
35
Book of Evidence, Tab 108
28
incomplete Korsakoff psychosis.” He also said that the Panel should conclude that Ms
SO was a “manipulating predator who engineered a criminal deception against United
Medical Protection with Dr GG (at least) as an accessory”. He later suggested that the
funds used to pay for his treatments may have come not from Ms SO’s superannuation
fund but rather from “criminal contacts”.
No evidence was produced in relation to any of these matters.
The Panel has set out these matters with some reluctance, but it has done so because it
considered it important to make a comment. The Panel is aware that the making of
these and other allegations is not the subject of the Notice or the hearing, but it
nevertheless wishes to express its dismay at the manner in which Dr Traill made very
serious unsubstantiated allegations and to state that it considers that this conduct
reflects poorly on Dr Traill.
In relation to Ms ST Dr Traill said in his written submission that “Apart from the bare
basics (that [Ms ST] had breast cancer, with recurrence in June 2000 which was not
biopsied and diagnosed for some months, and went on to have a mastectomy) virtually
all her evidence is false and misleading, to the point where the Panel should consider
assessing her for perjury.”
Dr Traill also said that Ms ST’s cognitive function may have been affected by the courses
of chemotherapy she had undertaken. He described some of Ms ST’s evidence relating
to events which were not the subject of allegations as vague and inconsistent and
argued that her other evidence was therefore tainted.
On several occasions the Panel asked Dr Traill to clarify how some of those matters
were relevant to the allegations.36 While Dr Traill made reference to “conflicts” in her
statements, it was only after Ms ST had completed her evidence and been excused that
Dr Traill said that he was asking some of those questions to test Ms ST’s credibility.
When the Panel expressed concern that he had not put that directly to Ms ST, Dr Traill
explained that he believed that there were inconsistencies in Ms ST’s evidence and said
“You [meaning the Panel] wanted me to talk about those in front of her and I wasn’t
going to say that I thought that I thought (sic) she was giving false and misleading
answers, but – because she was there, but I’ll say it now. …”37 Dr Traill expressed
concern that his questioning of Ms ST had been curtailed by the Panel and so he was
unable to reveal the inconsistencies he considered to be relevant to her credibility.
In addition, Dr Traill alleged that some witnesses had been paid to complain or appear
before the Panel. His exhibits contained similar allegations about other persons. As
indicated above, he made serious allegations concerning Dr GG about which he
produced no evidence.
In the course of the hearing and in his written submissions Dr Traill made comments
about the weight to be given to the evidence of other witnesses.
The weight to be given by the Panel to evidence and credibility of witnesses is a matter
for it and in accordance with the terms of the Briginshaw test which is set out above.
36
37
For example Transcript p. 184 ff
Transcript pp.288-289
29
The Panel has taken into account the concerns raised by Dr Traill about various
witnesses’ evidence, including those concerning Ms ST.
Professor Peters
While the Panel had regard to all of the expert evidence before it, the Panel gave
particular weight to that of Professor Peters, given his qualifications and his significant
theoretical and practical clinical experience. As indicated earlier, Professor Peters is a
Professor of Radiation Oncology at the Peter MacCallum Cancer Centre and the
Chairman of the Peter MacCallum Cancer Foundation. His curriculum vitae reveals that
Professor Peters:
•
•
•
•
•
•
•
Gained his qualifications at the Medical Schools of the University of Queensland
and the University of New South Wales. His post graduate training was
completed at The Royal Brisbane Hospital, the Queensland Radium Institute and
the Gray Laboratory of Cancer Research Campaign at the Mt Vernon Hospital in
Middlesex, England
He was certified in Radiotherapy and Oncology by the Royal Australian and New
Zealand College of Radiologists in 1971, in Radiotherapy and Oncology by the
Royal College of Radiologists in 1975 and in Therapeutic Radiology (Radiation
Oncology) by the American Board of Radiology initially in 1977 and again in 2001
He has held appointments in the field of radiology and oncology since 1971 in
Australia, England and the United States and has sat on and Chaired numerous
committees in both Australia and the United States of America
Since 1981 he has sat on a number of Editorial Boards, including the
International Journal of Radiation Oncology, Biology and Physics, Radiotherapy
and Oncology, The European Journal of Cancer; and the Journal of Clinical
Radiotherapy & Oncology
He is a member of a number of professional societies including the Royal
Australian and New Zealand College of Radiologists, the American Society of
Therapeutic Radiology & Oncology, and the European Society for Therapeutic
Radiology and Oncology
He has been awarded or won a number of scholarships and awards since 1966,
including three Gold Medals and he became a Member of the Order of Australia
in 2001 for his services to radiation oncology, particularly in respect to head and
neck cancer; and
He has been published more than 350 times.38
Allegation concerning Ms SO
Recommendation of full body hyperthermia treatment – Particular 1(a)(i)
The weight of evidence indicates that full body hyperthermia may be an effective
treatment when given together with radiation therapy and/or chemotherapy. In order to
be effective, it is necessary for the monitoring described earlier to be conducted, and for
the temperature to reach the range of 41°C and 45°C.
38
Book of Evidence, Tab 115
30
Dr Traill’s own description of the full body hyperthermia treatment of Ms SO indicated
that it was intended that the treatment be given in conjunction with chemotherapy but
that Ms SO refused to have the chemotherapy. As the Heckel tent had been set up for
Ms SO and, as Ms SO said that she wanted to proceed with the full body hyperthermia
treatment, it was commenced. Dr Traill said that Ms SO was unable to tolerate the
temperature and so the treatment was stopped after approximately 40 minutes. It
appeared that the temperature reached was less than 41°C.39 Ms Folan’s evidence was
to the same effect.40 No charge was levied for what was referred to as the abandoned or
failed treatment.
Leaving aside the fact that in a letter to the Board responding to Dr Traill’s comments Ms
SO denied that she was offered chemotherapy41, it is apparent that the possibly
beneficial combination of the full body hyperthermia treatment and chemotherapy was
not given to Ms SO.
In his report Professor Peters said that, as a therapeutic temperature was never reached
when Ms SO was given the full body hyperthermia, the treatment was not appropriate.
He also expressed the view that, as the treatment interrupted the standard treatment of
chemotherapy, full body hyperthermia treatment was inappropriate as of itself it had very
limited value.
On the basis of the evidence of Dr Traill himself, and the expert opinions of Professor
Peters and other experts, the Panel is satisfied that the full body hyperthermia treatment
given to Ms SO was not beneficial or effective.
When asked why he agreed to give a treatment which he knew was unlikely to be of any
benefit, Dr Traill said that he did so in an effort to treat the patient and not the disease.
He said that he hoped that if Ms SO had the full body hyperthermia treatment then she
may have later agreed to “some sort of chemotherapy” and maintained under cross
examination that he did recommend chemotherapy.42
The description of events suggests that, while full body hyperthermia with chemotherapy
was recommended by Dr Traill, he did not expressly recommend full body hyperthermia
on its own to Ms SO. In the Panel’s view, Dr Traill’s agreement to provide the full body
hyperthermia treatment without chemotherapy amounted to an implied recommendation.
In order to conclude that particular 1(a)(i) is made out, the Panel must be satisfied that
Ms SO had “potentially curable cancer”. This question was the subject of disagreement
between the Board and Dr Traill.
Dr GG treated Ms SO between January 2001 and August 2002. Dr GG also wrote to the
Board supporting Ms SO’s complaint about Dr Traill and provided two reports.43 His
evidence (given in the form of the two reports and oral evidence44) was, in summary:
39
Transcript p.554, Letter to the Board dated 26 December 2001, Book of Evidence, Tab 27
Affidavit sworn 21 February 2005, Book of Evidence, Tab 109; Transcript pp. 199-200
41
Letter dated 5 March 2002, Book of Evidence Tab 10
42
Transcript pp.649; 560
43
Letter dated 14 May 2000 with report attached, Book of Evidence Tab 11 and Letter dated 1 April 2005,
Book of Evidence Tab 11(a)
44
Transcript 293-408
40
31
•
•
•
•
•
As at August/September 2000, Ms SO had limited disease and, with a
combination of chemotherapy and radiation therapy, she could have had a 20%
chance of living for more than 5 years. He said that patients rarely relapse after
5 years, and so after 5 years patients are regarded as having a high probability of
having been cured;
The primary treatment for the disease was chemotherapy using regimens which
include a platinum based drug and etopicide. The treatments are given in cycles,
each of which consist of three treatment days followed by a gap of several
weeks. Usually at least four treatment cycles are given sequentially, and as soon
as possible one after the other to ensure that the small cell cancers do not
repopulate rapidly and drug resistance does not develop. In his view the “worst
thing” you could do would be to give a limited exposure to the drug and then stop
treatment;
The small cell carcinoma disease she had was very responsive to chemotherapy
prescribed by Dr Scarlett and this was supported by results of a CT scan taken
in October 2000;
The fact that Ms SO only had one cycle of treatment meant that it was likely that
the disease would grow back fairly fast; and
When Ms SO attended Peter McCallum for treatment after January 2001 she was
given chemotherapy which she tolerated quite well when also treated with antinausea medication. It was his view that, had such medication been given to Ms
SO in 2000, she would have been able to continue with the further recommended
chemotherapy cycles. His evidence was that, even when Ms SO returned in
2001 the disease was responsive to chemotherapy, which suggested that it
would have been more so in 2000.
Dr Peter’s evidence was that in his view Ms SO had a potentially curable disease if given
the conventional treatment, and that she had “probably been disadvantaged
significantly.”45
Dr Fox’s report46was based on his review of medical records provided to him. He did not
examine Ms SO. His report said, in summary:
•
•
•
•
45
46
As at August/September 2000 a CT Scan indicated that “within the limitations of
the screening technology” [Ms SO] had limited disease. However, there was
extensive metastic spread to nodes in the mediastinum, i.e. around the trachea.”;
By December 2000 it appeared Ms SO had progressive disease based on chest
x-rays;
As Ms SO had extensive mediastinal involvement, she would have had a
potential median survival of considerably less than 18% at 3 years had she had
optimal therapy;
Based on his review of the information, Ms SO could have expected at best to
have a 10-15% chance of survival for 3 years. He also commented that it
appeared that Ms SO had an aggressive form of lung cancer with an inadequate
response to chemotherapy, and so her long term disease free survival may have
been less than the 10-15% referred to above;
Transcript p.433
Book of Evidence, Tab 108
32
•
•
That some patients suffer severe toxicity with chemotherapy and do not proceed
with that treatment. He surmised that Ms SO did suffer severe toxicity with the
first cycle of treatment, and so withdrew which had the consequence that she
was placed into a very poor prognostic group; and
That the outcome “was really determined by her withdrawal from Dr Scarlett’s
treatment regime.”
Dr GG commented about Professor Fox’s report that almost everyone with small cell
lung cancers have mediastinum disease, but that did not prevent him from believing that
such a person could be cured. He also said that, in relation to the view expressed about
Ms SO’s possible survival rate, it was absolutely untrue on the basis that Ms SO’s
disease had responded to the first cycle of chemotherapy and it would be expected that
she would have continued to respond with further cycles. He said that the nausea Ms
SO experienced could have been controlled with appropriate drugs so she could have
continued. 47
It was Dr Traill’s submission that Ms SO was incurable on and after 5 October 2000. In
his view she had limited (rather than very limited) disease at that time which carries at
best an 8% 5 year survival rate. While she had a positive reaction to the first cycle of
chemotherapy undertaken with Dr Scarlett, it was not impressive enough to place her in
the 10% 5 year survival rate group. In addition, he said that calculations he made on
imaging studies indicated that she had extra-thoracic tumour deposits in the axilla and
brain greater than 1 mm in diameter on 5 October 2000 which made her incurable based
on current protocols. The evidence provided by Dr Traill to support this position was
contained in Exhibit 4. Dr Traill performed calculations using CT scans taken before and
after he completed the treatment of Ms SO. Based on doubling rates for tumours, when
applied backwards to 5 October 2000, his calculations indicated that she had extra
thoracic metastasis at that time.
It was the Panel’s view that the calculations and other matters referred to by Dr Traill
were all speculative and could not be shown to represent a useful description of Ms SO’s
condition.
Given that Dr GG in fact treated Ms SO, his opinion must necessarily carry greater
weight. The fact that he specialises in the treatment of small cell carcinomas is also of
significance. While it is clear that Dr GG has taken a personal interest in the case of Ms
SO and was hostile to the treatments offered by Dr Traill, those matters do not mean that
his professional opinion in relation to the chances of Ms SO being successfully treated is
to be discounted.
This Panel is naturally wary of expressing a view that Ms SO was or would definitely
have been in the group which could be regarded as curable. The Panel is able, though,
to conclude that, had Ms SO continued with the usual treatment of chemotherapy,
whether or not combined with radiation therapy, she would have had a chance of
survival. Whether that would have been the 10-15% or less chance of three-year
survival referred to by Professor Fox, or the 20% chance of more than five year survival
and effective cure referred to by Dr GG cannot be determined. Such a determination is
not required, though, to reach a finding in relation to particular 1(a)(i) as it is sufficient for
47
Transcript pp.315-319
33
the Panel to be satisfied that Ms SO had “potentially curable cancer”. The Panel is so
satisfied.
Allegation 1(a)(i) is made out.
Informed consent to full body hyperthermia treatment – Particular 1(a)(ii)
The Panel understands that this particular concerns the quality of the consent obtained
in relation to the whole body hypothermia referred to above. As is clear from the terms
of the particular, it is said on behalf of the Board that Dr Traill failed to provide to Ms SO
an adequate explanation about the treatment and the effect of her withdrawing from
chemotherapy treatment. It was also contended that Dr Traill failed to advise Ms SO
about what were regarded by the Board as the most efficacious treatments for her
condition.
Dr Traill relied on the terms of a document entitled “Deed of Acknowledgment Informed
Consent and Indemnity” executed by Ms SO on 5 October 2000 (“Deed”).48 The Deed
included the following statements:
“I acknowledge that I have been informed by the practitioner and clearly
understand that:1.1
That Wholebody Hyperthermia. Microwave (R.F.) Therapy, Bio
Modulation, Bio Immunotherapy, Bio Electric Therapy (Galvano) and any other
therapy will be administered only with my consent and by my request after
careful consideration following the practitioner’s recommendation.
1.2
Other modes of therapy for cancer are available such as:...
Radiation
Pharmocologic
...
1.3
I understand that this treatment regime for cancer is NOT held out as
a cure and that in the opinion of the majority of mainstream medicine,
particularly oncologists in Australia, this therapy is regarded as being
of little or even no value in the treatment of my cancer.
1.4
I understand that OncoCare International Pty Ltd trading as OncoCare
Clinic has made available treatment options which they believe may
be of help to me in my condition.
...
48
X-ray therapy, radium therapy etc.
Chemotherapy and phyto-pharmaceuticals
Book of Evidence, Tab 30
34
It was submitted by Mr O’Neill that, despite the terms of the Deed, Ms SO did not have
adequate information to give informed consent because Dr Traill did not properly advise
her about important matters such as that:
•
•
•
With appropriate radiotherapy and chemotherapy treatments she had a 20%
chance of a cure;
Her disease was responsive to chemotherapy; and
In order to maximise her chances of a cure, it was essential that she continue
with the regimen of treatment prescribed by Dr Scarlett, whether with him or
another oncologist.
It is the Panel’s view that, while the Deed makes it clear that no promise of a cure is
made by the OncoCare Clinic in relation to the treatments mentioned, it is insufficiently
clear in terms of which treatments are available to the particular patient and what
benefits may come from the other conventional treatments referred to.
The Book of Evidence contained a further document which is relevant to the issue of the
information given to Ms SO. Ms SO also signed that document entitled “Addendum to
Informed Consent, Understanding and Indemnity” on 5 October 2000 (“Addendum”).49
That document says:
“In presenting for treatment options offered by [OncoCare] you have been
asked to review carefully all the other choices of treatment available, in
particular, the time honoured conventional cancer treatments, namely, surgery,
chemotherapy and radiotherapy.
You are encouraged to ask questions not only of the practitioners at this Clinic,
but also of your surgeon, radiotherapist and oncologist concerning the
effectiveness of the treatment offered, as well as the side effects, both
immediately after treatment, and in the long term, as to your quality of life.
It is important, that you understand that the treatment offered at this Clinic is
not in opposition to conventional cancer therapy (chemotherapy and x-ray
therapy), but is offered as complementary and adjunctive.
It is therefore your responsibility to make an informed choice, based on
your understanding from the information given to you.”
The weight to be given to this document in the case of Ms SO depends on certain events
relating to the termination of her treatment with Dr Scarlett.
In her statement given to Dr Middleton and then reviewed by her, Ms SO said that she
was informed by Dr Traill that she could not continue to see Dr Scarlett as that would be
seen as poaching of patients and that, if she wanted to be treated by Dr Traill she could
only see him. In her letter to the Board dated 5 March 200150 Ms SO said that she was
told that she could not be seen by two doctors at once as that would be “unethical”. Dr
49
50
Book of Evidence, Tab 29
Book of Evidence, Tab 10
35
GG was also of the understanding that Dr Traill had insisted that Ms SO sever all ties
with Dr Scarlett.51
In a letter to the Board, Dr Traill said that he advised Ms SO that he would not undertake
any treatment unless either the Senior Oncologist (Dr Scarlett) was agreeable to the
treatments offered, or she chose not to continue with Dr Scarlett.52 Dr Traill confirmed in
his oral evidence that he presented Ms SO with this either/or option and that she chose
the latter – it should be noted that Ms SO denied being given the option to seek Dr
Scarlett’s consent to the treatment.53
In the Panel’s view, once Dr Traill was on notice that Ms SO had elected not to continue
with Dr Scarlett and so did not have ready access to another practitioner for advice
about conventional treatments, including chemotherapy and radiotherapy, he could not
rely on the terms of the Addendum in relation to obtaining informed consent. In addition,
it is the Panel’s view that it was imperative that Dr Traill ensure that Ms SO understood
the consequences which could flow from determining not to continue with chemotherapy.
Dr Traill stated that his advice to Ms SO was to continue with chemotherapy but she
refused. In evidence in chief he said that chemotherapy was recommended and that Ms
SO opted to have the 434 Mghz treatment “against my advice in being the optimum
treatment”.54 In cross examination Dr Traill said that he was trying to get Ms SO to have
chemotherapy and that he presented an argument to her that her condition was
potentially curable in terms of long term remission. He said that Ms SO refused the
chemotherapy and at that point as far as he was concerned she became a palliative
patient.55 Dr Traill’s notes show that he recorded the fact that Ms SO had been having
chemotherapy with Dr Scarlett and that she did not want any more.56
Ms SO in her correspondence and statement confirmed that she had reacted badly to
the first cycle of chemotherapy and that she did not want to continue. In her March 2001
letter, Ms SO said though that she was not informed by Dr Traill that chemotherapy was
the best way to achieve long term remission. She said she was offered low doses of
chemotherapy that would have had no side effects and which she “believed as such
would be ineffective”. She also said that palliative care was not mentioned to her and
that she would not have commenced treatment with Dr Traill if that treatment had been
described as palliative as she “did not consider [herself] in need of palliative treatment at
that stage.” In addition, Ms SO said in her letter Dr Traill did not say to her that he did
not believe she had many treatment options left.
Dr GG had two telephone conversations with Dr Traill in early February 2001 concerning
the treatment of Ms SO. In the course of those conversations Dr GG formed the view
that Dr Traill was unaware that Ms SO’s disease was treatable and potentially curable.
He said in a report attached to his letter to the Board57 that Dr Traill telephoned him
some days after an initial discussion in which Dr Traill outlined the treatments given to
Ms SO.
51
See letter to the Board dated 14 May 2001, Book of Evidence Tab 11
Book of Evidence, Tab 27
53
Transcript p.560; Letter dated 5 March 2001, Book of Evidence, Tab 10
54
Transcript p. 555
55
Transcript p. 642
56
Book of Evidence, Tab 15
57
Book of Evidence, Tab 11
52
36
In the second discussion Dr GG said that he asked Dr Traill “if he realised that the
patient had postentially (sic) curable disease when she saw him and he did not. He
maintained that she was having treatment for incurable malignancy and that the
treatment was ‘palliative’.” Dr GG went on to say that “Dr Traill appeared to me to be
entirely ignorant of the modern medical management of small cell lung cancer during this
conversation.” This recollection and opinion were confirmed by Dr GG on cross
examination.58
Dr Traill was asked specifically about the content of this report and the description of the
discussions in cross-examination. His evidence was that Dr GG’s interpretation of the
discussion was incorrect, that he was “caught on the hop” and that he was speaking “off
the cuff”. Dr Traill went on to repeat his view that Ms SO had rejected chemotherapy
and so she was thereafter a palliative patient.
Dr Traill’s notes contain diary notes of the two discussions with Dr GG. There are
references to Dr GG saying Ms SO had a curable condition and his concerns about her
not being treated but no record of responses by Dr Traill. In his written submission Dr
Traill states that he was aware that that there was a potential for long term remissions for
patients such as Ms SO.
On the one hand the content of Ms SO’s letter to the Board and her statement of
recollections recorded by Dr Middleton say that chemotherapy was not recommended by
Dr Traill and that no information about chemotherapy offering a chance of long term
remission was given to her. Certainly neither the Deed not the Addendum offer that
information. Ms SO’s recollections are supported by Dr GG’s recollections of what she
told him. The evidence concerning the telephone call held between Dr Traill and Dr GG
suggest that Dr Traill was unaware that a treatment which could be effective for Ms SO
was available.
Even if those discussions are put to one side and no adverse conclusions about Dr
Traill’s knowledge are drawn, serious concerns arise about the nature of the consent
obtained.
In addition, it must be noted that Ms SO commenced and completed a course of
chemotherapy once she had been referred to Peter McCallum in January 2001. Dr GG
described Ms SO as a co-operative patient and he believed that, had the detailed
discussions held in 2001 been held in 2000, she would have accepted conventional
treatments. Dr GG said that Ms SO said words to the effect that she understood what
was being offered by Dr Traill was mainstream and that she would have been crazy to
have agreed to and paid so much for a completely unproven treatment.59
There is no reference in Dr Traill’s notes to him explaining to Ms SO that chemotherapy
was the treatment he believed offered the best chance of long term remission or to the
fact that he regarded her as a palliative patient. The evidence given by Dr Traill
indicates that he accepted the decision of Ms SO without testing the basis for it or trying
to persuade her to reconsider chemotherapy. The fact that Dr Traill said he intended to
ease Ms SO into chemotherapy after getting her confidence through the full body
58
59
Transcript p.353-354
Transcript p.319-320
37
hyperthermia suggest a failure to provide clear and direct information to Ms SO to
consider.
Ms SO in her correspondence to the Board said that both treatments were referred to by
Dr Traill and on the invoices as hyperthermia. Dr Traill’s description of the events
leading to Ms SO having 434 Mghz treatment do not indicate that he described the
effects of that treatment. In his letter to the Board dated 26 December 2001 60Dr Trail
said that this treatment was referred to loosely as hyperthermia as that was what
patients could understand. In the statement given to Dr Middleton Ms SO said that she
understood the 434 Mghz treatment was additive and was included in the regime as a
favour to her.
The Panel is satisfied that Dr Traill failed to provide Ms SO with adequate information to
obtain her informed consent to the full body hyperthermia treatment and/or the 434 Mghz
treatment and in particular he failed to advise Ms SO that her withdrawal from the
planned chemotherapy cycles could adversely effect her health and prognosis and that
the most efficacious treatment for her cancer was cytoxic chemotherapy and thoracic
radiation.
434 Mghz treatment and its effects – Particular 1(a)(iii)
Dr Traill’s evidence was that he recommended chemotherapy to Ms SO and, when she
refused, he said that all he could offer was the 434 Mghz treatment.61 As stated earlier
he did not regard that treatment as optimal for her condition.
The overwhelming expert evidence was that the use of 434 Mghz treatment is unproven
and that, other than limited material, most of which has been written by Dr Holt there is
no published material indicating that it has any clinical application. It is fair to say that all
of the medical practitioners who gave evidence to the Panel other than Dr Traill regarded
the treatment as useless.
Dr Traill provided the Panel with information about the treatment as discussed earlier in
these reasons, but he did not produce any expert evidence or an expert report which
supported his use of the 434 Mghz treatment for Ms SO or the other 2 patients.
In his evidence Professor Peters referred to a paper written by Dr Holt entitled The
unique exponential growth of life is powered by anaerobic glycolysis. 62. He quoted the
following passage from page 204 of that paper:
“Between 1973 and 1991 approximately 10 000 patients were treated with UHF
followed by 150 rads ionizing radiation to between 3000 and 45000 rads total.
No recurrences within any treated areas were seen.”
He said: “This is astonishing. I mean nobody could treat 10,000 cancer patients and
never have a single failure. But this is the sort of ‘evidence’, if you like of efficacy of this
treatment. There have been no definitive trials done and no scientifically credible
60
Book of Evidence, Tab 27
Transcript p.560
62
Published in the Journal of Molecular Liquids 114 (2004) 193-206, Book of Evidence, Tab 106(a)(i)
61
38
evidence of efficacy, it’s just these extraordinary assertions and testimonials from people
that are used to legitimise the treatment.”63
Dr Drummond’s reaction to that passage was that she was skeptical about the claimed
results, the doses of radiation appeared low, doses had not been referred to in terms of
“rads” for some 10 or more years, and that this was not a conventional way to report
results of findings of clinical studies.64
On a number of occasions before he commenced his case, Dr Traill was asked to
provide any expert reports or other material about the treatments so that the experts for
the Board could consider them. While some limited material was provided at that point,
it did not include details of any trials or scientific review of the treatment.
During cross examination Dr Traill was again invited to provide information about trials,
independent assessments and/or evidence about the effectiveness of the treatment.
What was available to the Panel to show the treatment had a beneficial affect included
Dr Traill’s description of how he believes the treatment works and some articles written
by Dr Holt which contain anecdotes about his patients and his descriptions of treatment
successes. It is interesting to note that Dr Traill indicated that he did not agree with
some of Dr Holt’s methods or conclusions and so information from Dr Holt cannot on its
face be entirely relied on to support the methods employed by Dr Traill.
In addition to the article by Dr Holt quoted by Professor Peters, at the request of Counsel
Assisting, Professor Peters also located and provided to the Panel an article considering
whether there was any evidence of cytotoxic effects from certain microwave frequencies
including 434 Mghz. The study concluded that the results presented “suggest that the
nonthermal component to cell killing, if at all present, is very small at any of the
frequencies studied.”65
Counsel Assisting provided to the Panel an article which reported on a randomised study
as to the effect of a combination of 434 Mghz treatment with external beam radiotherapy
as compared with standard external beam radiotherapy for the control of locally recurrent
and primary unresectable rectal cancer. The study concluded that combined therapy
produced no therapeutic advantage over the conventional treatment.66
As stated earlier, Dr Traill expressed the view that no witness called before the Panel
was his peer or had the expertise to comment on the 434 Mghz treatment. He said in
particular none had any experience with, or significant knowledge of the science relating
to the 434 Mghz treatment and no expert had the background in chemical pathology, or
any other branch of pathology, to understand or comment upon biochemical and
biophysical matters as a peer or expert. Further in Dr Traill’s submission no witness
could be said to be an expert in the use of radio frequency, non-ionizing irradiation and
its effect upon tissues.
63
Transcript pp.115-116
Transcript pp.277-278
65
Exhibit B - “Microwave Cytotoxicity: Lack of in Vitro Evidence for Nonthermal Effects at High Power
Levels”, Radiation Research 89, 124-133 (1982)
66
Exhibit D - JM Trotter, A J Edis, J B Blackwell, M H Lamb, E J Bayliss, J M Shepard and B Cassidy,
Australasian Radiology (1996) 40, 298-305
64
39
Even if this view were accepted, a very serious difficulty is that there was no material put
before the Panel by Dr Traill which gave a coherent or scientifically rational explanation
of the treatment. By saying scientifically rational, the Panel means some material more
than Dr Traill’s own explanation of how he believes 434 Mghz treatment works and more
than photographs which were said to show “the resonance phenomenon”.
Ms Folan was a nurse employed at the OncoCare Clinic at the time of the relevant
events. She operated the two machines at the clinic for the 434 Mghz treatments given
to Ms SO.
Having said that she did not necessarily understand how the machines worked, she
gave evidence about how she operated them. She was told how to operate the
machines by Mr David Spall, the Chief Executive Officer and Director of OncoCare
International Pty Ltd, who has a medical qualification from Colombo. She said that Mr
Spall told her how to adjust the dials and run it within the guidelines. Asked whether
there was a dial that showed that 434 Mghz were being delivered, she answered no and
that she assumed that the machine had been set to deliver that frequency. She was
asked whether there was any dial or instrument on the machine to change the wave
length and replied no. She said that there were dials on the different antennae of the
machine and to run them properly she had to keep them as low as she could. She said
that she would alter the machine as the microwaves would react differently as they
passed through different parts of the body. She was unable to say what the adjustments
did in terms of the microwaves being emitted. She said that the machine did give off
heat and, when the patient became uncomfortable, she would turn the machine off.
The usual instructions were for a patient to have three cycles of six minutes duration.
Ms Folan’s evidence was that the treatment was given in the same way for all patients
without adjustment for their size or weight or the location of the cancer.67
To be fair to Ms Folan it was evident that her recall of the detail was not complete and it
was apparent that, while she had responsibility for operating the machines, she was not
asked or expected to understand the precise workings. On reviewing the transcript of
her evidence it seems that at times there may have been some confusion about whether
she was talking about the hyperthermia treatment or the 434 Mghz treatment.
In any event, it appeared to the Panel that there was a lack of any scientific rigour in how
any of the treatments were delivered.
Dr Traill’s position as stated in his submission in relation to the treatment in the case of
Ms SO, was that it slowed the growth of the tumour and led to her living longer. This
position was in part based on the opinion of Professor Fox that, as at October 2000, Ms
SO had an incurable condition and that she was unlikely to be in the group which had
the best survival rate, and also on the calculations made by Dr Traill which were
discussed earlier under particular1(a)(i).
By contrast Dr GG’s opinion was that when a CT scan was conducted in December 2000
it showed a progression of the disease in her chest. He referred to her having prominent
neck veins and mild plethora which were, in his view, suggestive of early superior vena
cava obstruction which he described as “a potentially lethal complication of uncontrolled
67
Transcript pp.219-227
40
lung cancer.”68 When reviewing the x-rays taken on or around 5 October 2000 he
commented that Ms SO appeared to have had an excellent response to the first cycle of
chemotherapy and that the tumour was responsive.69
The 434 Mghz treatment is not just a new or novel form of treatment with limited use
which is subject to appropriate testing and peer review. There have been no proper
clinical trials to assess its effectiveness. There was no coherent scientific basis for the
treatment before the Panel and no systematic review of its usefulness even on a small
scale. Dr Traill appeared to be of the view that the Panel members simply did not and
could not understand how the treatment worked. To the degree that no evidence was
presented to show it had any effect, not to mention a beneficial one, Dr Traill was
correct.
It is the view of the Panel that the 434 Mghz treatment given by Dr Traill was of no
benefit and had no beneficial effect on Ms SO. As discussed above in relation to
particular 1(a)(i), the Panel is satisfied that Ms SO’s cancer was potentially curable.
In the view of the Panel the particular is made out.
Charges to HIC for chemotherapy treatment - Particular 1(a)(iv)
According to an undated document apparently issued by the HIC various item numbers
apply to a number of different chemotherapeutic treatments.70 The Panel’s attention was
drawn to item 13915 which is described as “CYTOTOXIC CHEMOTHERAPY,
administration of, either by intravenous push technique (directly into a vein, or a butterfly
needle, or the side-arm of an infusion) or by intravenous infusion of not more than 1
hours duration – payable once only on the same day. Fee: $50.05 Benefit: 75% =
$37.55 85% = $42.55”.
The Book of Evidence also included a copy of a letter from the HIC dated 10 January
2002 addressed to the Deputy Chief Executive Officer of the Board.71 The letter set out
a list of services rendered by Dr Traill for Ms SO between 1 August 2000 to 30
November 2001 for which a claim for Medicare benefits was processed and paid. The
list included 15 services carrying item number 13915 with a benefit of $42.55.
The Book of Evidence included a standard form sheet which was said to show the
treatments given to Ms SO. The sheet had a number of columns in which details could
be written to show the date and start and stop times for various treatments.72 A section
of the form was headed “Chemo” and had columns for the start and finish times for the
treatment. These columns were blank.
As stated earlier, in her correspondence to the Board, Ms SO said that she was not
offered any chemotherapy treatment from Dr Traill. Ms SO said that the injections she
was given were charged at $50 each but that an amount was rebatable and that she
signed a Medicare form for those injections.73
68
Report attached to letter dated 14 May 2001, Book of Evidence, Tab 11
Transcript pp..398-399
70
Book of Evidence, Tab 55
71
Tab 31
72
Book of Evidence, Tab 18
73
Statement dated 29 January 2002, Book of Evidence, Tab 9
69
41
Dr Traill’s evidence was that Ms SO did in fact receive chemotherapy. He said that Ms
SO was given intravenous injections of oxidized glutathione and S-methyl L-cysteine
sulphoxide which “in this context with UHF 434 MHz, is non-physiological and
cytostaic/cytotoxic.” He referred to this substance in evidence and in his submission as
an “infusion”. He further said that the definitions of “chemotherapy” and “cytotoxic” in the
glossary of “Euthanasia, Clinical Practice and the Law”74 “include the use of the above
infusion, concurrently with 434MHz, within the meanings.”
The definitions to which Dr Traill referred the Panel are as follows:
•
•
Chemotherapy: “literally a general term for the treatment of disease by means of
chemical substances or drugs. Now usually limited to the treatment of cancer by
chemical substances”; and
Cytotoxic drugs: “drugs that suppress reproduction of cells. Among other uses,
are employed to suppress the rapidly growing cells of certain types of cancer”
In relation to this matter, Dr Traill said in his submission that:
•
•
•
•
No witnesses were produced who could be considered as ‘experts’ on this topic;
Ms SO “refused chemotherapy of the standard type which had predicable (sic)
toxicities. The infusion was not described to her as chemotherapy because it did
not carry the general toxicities which she stated she could not bear”;
The “chemo” heading on the treatment sheet referred to above refers to
chemotherapies which are not part of the standard 434 Mghz treatment; and
As a clinical expert in Pathology Dr Traill states that infusion concurrently with
434 Mghz constituted chemotherapy.
The infusion was also referred to from time to time as a “glucose blocker” which, in his
written submission, Dr Traill explained was a term coined by Dr Holt because it “may
reduce the number of electron donors in solution and thereby impede the anaerobic
breakdown of glucose, it may indirectly block glucose usage.”
In cross examination, Dr Traill was asked to show that the infusion was in any way
cytotoxic or a chemotherapeutic treatment. Dr Traill said:
“I have shown in some patient’s graphs that show that there have been a
beneficial [effect] which is due to the treatment which I believe is part of this
treatment which is cytotoxic on cells or cytocidal.”75
He was asked to show any confirmation from any government body or anyone else that
acknowledges that the substance he used is regarded as chemotherapy or as falling
under the item number. Dr Traill said that he had not been asked to define it, that he
was aware that Dr Holt had been using the substance for at least 35 years and as far as
he was aware Dr Holt’s claims had been paid. Asked if he had ever written to the HIC to
say that he regarded the substance as chemotherapy, Dr Traill said:
74
75
Editor Luke Gormally, 1994, pages 97-98
Transcript pp.621-622
42
“No, because I interpret it to being cytotoxic so as far as I’m concerned it’s a
chemical cytotoxic in that context and therefore it is a cytotoxic drug.”76
Later there was this exchange:
Mr O’Neill: “I want to put to you doctor that this is a sham and a fraud and
there is no basis whatsoever where you can justify the charging of this item
when you do not give – have not given chemotherapeutic treatment to [Ms
SO]?”
Dr Traill: “As far as I’m concerned it fulfils the criteria in the definitions here
[referring to the definitions in Gormally’s book]. And I think they are good
enough given the background and the historicals.”77
On 5 October 2000 a letter was sent from the OncoCare Clinic to Ms SO concerning the
cost of proposed treatment. The letter made reference to an “Infusion fee (Item No.
13915)” and the Medicare rebate. The letter though referred to the treatment being
regional microwave hyperthermia for 15 treatments rather than 434 Mghz treatment.78
It is interesting to note that the infusion, while referred to in Dr Traill’s submission to the
NHMRC Review, is not described as chemotherapy. Similarly, in his correspondence to
the Board there was no reference to the infusion as being chemotherapy.
The nature of the infusion was described to a number of the expert witnesses all of
whom would be expected to be most familiar with current and past chemotherapy
treatments and none regarded that infusion as meeting the description. Even on Dr
Traill’s own definitions there is nothing to show that the infusion has any suppressing
effect on cancerous cells.
It is the Panel’s view that on a simple reading the term chemotherapy must refer to a
substance or form of treatment which has a therapeutic effect on cancerous cells. It
must be a proven or established treatment for the disease.
In the view of the Panel Dr Traill’s use of the term chemotherapy to describe his infusion
and to use item number 13915 for its administration is entirely without foundation. If Dr
Traill’s approach were to apply, any chemical substance which is thought to treat cancer
could be called chemotherapy and charged to patients and the HIC as such. That would
be untenable.
The particular is made out.
Lithium - Particular 1(a)(v)
In his report Professor Peters expressed the view that lithium has no anti-cancer activity.
He said that while Tamoxifen is effective against oestrogen receptor positive breast
cancer until the cancer becomes hormone refractory, this would not have assisted Ms
ST in his view, as the information available indicated that she was oestrogen receptor
76
Transcript pp.622
Transcript pp. 624
78
Book of Evidence, Tab 24
77
43
negative. In his evidence Professor Peters also noted that it may be used where the
patient may have a psychiatric disease and receives lithium concurrently with cancer
treatment.79
Dr GG’s evidence was that he could not understand why lithium would be given to a
cancer patient other than in limited circumstances where chemotherapy had caused
bone marrow toxicity or where the patient had a psychiatric condition. He also noted that
it was important to monitor lithium levels because patients can suffer severe toxicity from
lithium.80
Dr Drummond’s evidence was that she was not aware of lithium being used in the
treatment of cancer generally and certainly not in relation to breast cancer which is her
area of specialty.81
If we are to take Dr Traill’s information notes as the basis for his explanation as to the
usefulness of lithium in cancer treatment generally and particularly for Ms SO, it is
apparent that it is an experimental treatment in that context and it appears to be based
on hypothesis on hypothesis. No evidence or information was provided by Dr Traill to
show that it had a beneficial or other effect on Ms SO’s illness.
In these circumstances it is the Panel’s view that the treatment given was unnecessary
or not reasonably required and so the particular is made out.
Monitoring of Lithium – Particular 1(a)(vi)
One reason for there being concern about the monitoring of lithium is because it can
have severe toxic effects.
A pathology report dated 3 November 2002 shows a measurement of lithium in a sample
taken from Ms SO.82 It would appear to be the only such measurement taken.
In his submission Mr O’Neill made reference to that report and then said “It is a matter
for the Panel to determine whether, having provided Lithium, Dr Traill monitored it
appropriately.”
The particular as drafted is limited to whether or not Dr Traill monitored the lithium in Ms
SO’s blood. Given that the period of treatment with lithium lasted for only approximately
a month, one blood test measurement would appear to be adequate. The particular is
therefore not made out.
Charges for Treatment – Particular 1(a)(vii)
Dr Traill said that his charges for the treatments reflected commercial considerations and
noted that Ms SO accepted the amounts which were quoted in advance and throughout
the treatment course. He also said that she was aware that she was not having
potentially curative treatment. Dr Traill stated that the Board had failed to provide
79
Transcript p.113
Transcript pp.302-303
81
Transcript p.262
82
Book of Evidence, Tab 22
80
44
reliable information about her financial position and so comments about her ability to pay
were not admissible. The choice to embark on the treatments and pay the quoted costs
were seen by Dr Traill as Ms SO’s choice.
He went on to make general comments about the costs to the effect that the fees
charged are much the same as, or less than, a full in vitro fertilisation course and a lot
lower than treatments conducted in private clinics in Germany and Mexico.
In considering this question the Panel has not taken into account the full body
hyperthermia treatment given to Ms SO for which she was not charged.
Having concluded that:
•
•
•
•
•
Ms SO had potentially curable disease which ought to have been treated with
chemotherapy and radiation therapy if the small possibility of survival was to be
available to her;
it appeared to the Panel that Ms SO believed the treatments given were more
than palliative and were intended to treat her illness;
the consent obtained from Ms SO in relation to all treatments given was
inadequate;
the 434 Mghz treatment was not beneficial or effective; and
the administration of lithium was unnecessary or not reasonably required,
the Panel finds that the charges for those treatments were excessive.
The particular is made out.
Inadequate follow up – Particular 1(a)(viii)
In her statement Ms SO said that at the end of treatment she was told that she should
attend a consultation with Dr Traill and Mr Spall and that would cost $150. She said that,
as she did not have the funds to pay the cost, no such consultation was held. She also
said that no x-rays were ordered at the end of the treatment and that no follow up was
arranged.
Dr Traill denied that any such final consultation at a cost of $150 was proposed. He also
said that he told Ms SO to return in a month but she failed to do so because at that stage
she was in the Leongatha Memorial Hospital and under the care of her general
practitioner. She then went to Peter MacCallum Hospital for treatment.
Dr Traill said that the suggestion to return in a month was made during a telephone call
held with Ms SO on 14 November 2000.83 Dr Traill’s notes have an entry which may be
that date which appears to record a discussion with Ms SO and ends with “Rev 1/12”.
Ms Folan said that her understanding was that a final consultation was often held with
patients and they could return later but that depended on the discussions held at the
consultation.
83
Book of Evidence, Tab 27
45
It would appear that it was intended at least by Dr Traill for Ms SO to be reviewed by him
in a month and so the particular is not made out.
Oncology specialist – Particular 1(a)(ix)
Ms SO said in her statement that she was told by Dr Traill that he was an oncologist.
As indicated by the curriculum vitae referred to earlier, Dr Traill says that he studied
oncology under the tutelage of Drs Bean and Bolton. In his submission Dr Traill says:
•
•
•
•
He is a “Fellow of the Royal College of Pathologists of Australasia. This entails
formal postgraduate training in the study of cancer (Oncology), being a study of
the causation, the behaviour, the morphology, the diagnosis, the categorisation of
cancers and the mode of actions of chemotherapeutic drugs and ionizing
radiation upon cancers and sarcomata.”;
He is categorised as a Specialist Consulting Pathologist which entails the
application of pathology training in the clinic. He also states that he has
published papers on cancer, its classification, inheritance and treatment;
There are some doctors who believe that, by acquiring qualifications or self –
styled attributes, that they are the only ones who can understand, diagnose and
treat certain conditions. In his view those qualifications and attributes do not
mean those doctors are safer with patients; and
As referred to earlier, the use of titles such as oncologist is related to a turf war.
When questioning some witnesses about this particular, Dr Traill asked questions which
indicated that he regarded anyone with a special interest in oncology as being entitled to
call themselves “oncologists”. That suggestion was rejected by those to whom it was
put.84
The evidence given by the experts called showed that they had undertaken specialist
formal study and training. The qualifications and experience of Professor Peters has
been noted earlier. All expert evidence was to the effect that oncology is a specialist
area of practice and more than an area of special interest as asserted by Dr Traill.85
Professor Peters' evidence was that there were for the purposes of the HIC recognised
oncology specialists, that there is a specialty of oncology recognised by the College of
Physicians, and specialities recognised by the Colleges of Radiology and Surgery.
In considering this matter, the Panel has not adjudicated as to whether there is an
exclusive club of the type described by Dr Traill. It has considered whether Dr Traill has
any specialist qualifications of the type held by the experts called by the Board. While
the Board recognises Dr Traill’s extensive pathology training and experience, it simply
cannot be said to be equivalent to or a substitute for the qualifications and training in
treatment discussed.
It is important to consider the effect of the use of terms such as “Oncologist” in the eyes
of members of the public generally and, most importantly, patients. In the Panel’s view,
such a term suggests that the medical practitioner has trained in the relevant area, has a
84
Professor Peters – Transcript pp.427-430; Dr Drummond – Transcript p. 266; Dr DD – Transcript pp.472473; Dr GG – Transcript pp..368-370
85
See above
46
specialist knowledge of the particular disease , is involved in treatment of that disease
and is engaging in recognised treatments for that disease. In simple terms a member of
the public or a patient would expect that the medical practitioner using that term is seen
by his or her peers as an expert in terms of study and practice. Dr Traill’s experience
and qualifications do not meet that description and do not, in the Panel’s view, lead to
him being properly entitled to call himself an oncologist.
The particular is made out.
Monitoring – Particular 1(a)(x)
Dr Traill took regular blood and urine tests for Ms SO and one of the measurements he
sought and reviewed was the uric acid levels. In his submission he explained that they
were measured to assess the endogenous Purine turnover, as Ms SO was a vegetarian.
He said that the test was not “for monitoring the progress or condition of her cancer per
se.” He also said that uric acid measurement is supported by the literature on small cell
lung cancer and was later measured when Ms SO was being treated at the Peter
MacCallum Hospital.
In the course of the cross examination of Dr DD there was a discussion of the purpose
for monitoring uric acid levels. Dr Traill asked whether uric acid could be a tumour
marker. The response was that it was not a tumour marker but it could indicate that the
patient has hyperuricemia which is a potentially fatal complication arising from tumour
break down.
By contrast to the above statement from Dr Traill’s submission, his questioning of Dr GG
appeared to suggest that he believed the uric acid levels were related to the effects,
firstly of the chemotherapy cycle, and then his own treatment. A graph was produced
which Dr Traill referred to at this time.86 When being cross examined by Mr O’Neill he
said the following:
“All I can say is it’s a measure of purine turnover. It’s not a tumour marker as
such. It’s a rather non-specific thing but if used in the right context with the
right understanding, the right background, I think one can obtain useful
information from it.
. . . At this stage of the piece when she had just finished chemotherapy it
reflected probably a breakdown of the previous chemotherapy and that was
shown mainly in the urine level. Thereafter, when we started the [434 Mghz]
treatment about here, there was a steady rise which went quite high . . . So one
can conclude from that, (1) That tumour breakdown at the beginning from
chemotherapy wasn’t very impressive. There was well in the normal reference
range. There seemed no risk of getting the tumourlysis syndrome, we weren’t
looking at an impressive fall.
. . . All I’m saying is in the context that she is – was a known vegetarian which
means that the urate that was coming out would reflect endogenous purine
breakdown . . . the significance of this – she was the first patient I wanted to try
and assess, whether the [434 Mghz] had some measurable affect on patients
86
Transcript pp.342-345
47
as I could use as a sort of an indicator that this treatment was actually doing
something. . . . I was very keen to try and get some evidence to show that the
[434 Mghz] treatment in the short term at least would influence cell metabolism
which was in this context, would be largely cancer cells.”87
Dr GG described the measuring of urate levels as “pseudo-science” and “nonsense”.88
In the Panel’s view Dr Traill’s own evidence indicates that his use of measurements of
uric acid levels was experimental and undertaken as part of his efforts to show that the
434 Mghz treatment has “some” effect. Even if in fact it shows “some” effect, what that
effect is was not apparent to the Panel. The evidence indicates that the measurement of
uric acid levels was not a usual method to monitor a cancer patient and may have added
nothing to Dr Traill’s assessment of the progress of the 434 Mghz treatment.
In her statement Ms SO said that x-rays were not taken to monitor the progress of the
434 Mghz treatment. She said that it was only when she asked for an x-ray to be
performed that this was done. An x-ray was taken on 5 October 2000 and it was
understood by Ms SO to show that the tumour had reduced by half, which she believed
was a consequence of the earlier chemotherapy she had under Dr Scarlett. She said
that Dr Traill said that the reduction was probably a result of the 434 Mghz treatment
boosting the effect of the chemotherapy.
In his submission Dr Traill said that x-rays were ordered both before and after the 434
Mghz treatment was undertaken on 5 October and 9 November 2000. He noted that Ms
SO had a CT-scan just before the chemotherapy with Dr Scarlett and, given the expense
involved, he regarded an x-ray as adequate. Dr Traill also said that, as Ms SO was lost
to follow up, he could not order a CT-scan 6 weeks after the completion of treatment as
he had intended.
Dr GG’s evidence was that the best way to monitor the progress of Ms SO’s tumour
would have been by taking a CT scan.89
In the Panel’s view the monitoring of uric acid by Dr Traill does not amount to adequate
monitoring of his patient as described in the allegation.
In circumstances where Dr Traill was aware that he was the sole treating medical
practitioner for Ms SO, the Panel considers that a CT scan would have been the
preferred form of monitoring to determine whether the tumour had increased or spread.
However, as discussed earlier, given that Ms SO did not return for any further follow up
after the approximately 8 week period of treatment, and given she was shortly thereafter
admitted to hospital under the care of another medical practitioner, the Panel does not
consider this aspect of the particular is made out or would in any event of itself amount
to unprofessional conduct.
87
Transcript pp.644-646
Transcript p.303 and 345
89
Transcript p.303
88
48
Ineffective and time consuming treatment – Particular 1(a)(xi)
Dr Traill says that Ms SO determined her own treatment course within the range offered
in that she rejected chemotherapy and elected to have the 434 Mghz treatment. She
had proper medical advice from himself and her general practitioner. He says that no
evidence has been brought to show that the 434 Mghz treatment was ineffective and in
fact in his view it induced slower growth. He also states again that at the time she came
to him Ms SO did not have a potential cure.
In his written submission on this point, and in a more general section, Dr Traill refers to
his patients as being entitled to make their own choices and that, if they elect to “drop
out of recommended treatments, and this cannot be prevented except by certifying them
mentally insane.”
He says of patients who reject recommended treatment or management “Someone has
to treat them – they cannot be thrown onto the street. It is better that those who treat
such people are in the medical profession. The medical profession must be flexible to
individuals’ wishes.”
In the hearing Dr Traill was asked whether he recommended the 434 Mghz treatment to
Ms SO. He replied:
“I didn’t recommend it. I recommended chemotherapy. She said ‘I wasn’t
going to have . . . She said she wouldn’t have it, she wouldn’t have the
hyperthermia and I said the only other treatment we can offer this on the
shopping list. . . . She can have it is she likes, and she said, ‘I’ll take it’. . . . I
didn’t recommend it . . . My recommendation was chemotherapy and stays
chemotherapy.”90
The Panel has already concluded based on the evidence, that if treated with
chemotherapy and radiation therapy, Ms SO would have had a chance of falling within
the group who could be described as cured in the sense that there are no recurrences of
cancer for 5 or more years.
The x-ray and CT scans taken at the end of the first cycle of chemotherapy indicated that
the chemotherapy had been effective and so it could be expected that effectiveness
would have continued.
In the light of the views expressed by the Panel about the particular which raised the
effectiveness or otherwise of the various treatments given to Ms SO by Dr Traill and the
quality of the consent obtained (particulars 1(a)(i), (ii), (iii) and (v)) it is satisfied that Ms
SO was denied proper medical advice from Dr Traill.
The question of whether Ms SO was denied the chance of a cure is difficult. It is
necessarily a matter of speculation as to whether it is more likely than not that, if Ms SO
had been told that the most effective treatment was chemotherapy and radiation therapy,
she would have sought further advice from Dr Scarlett or another medical practitioner. It
would also be speculative to conclude that she could have been cured.
90
Transcript p.560
49
The particular cannot be said to have been made out because of the nature of the
speculation which would be required to be engaged in by the Panel.
Allegation concerning Ms ST
Recommendation for microwave and local hyperthermia – Particular 1(b)(i)
Taking into account cross examination of Dr Traill in which Mr O’Neill sought clarification
of the treatments administered to Ms ST and the following amendment of the allegation
and the fact that Dr Traill indicated that 434 Mghz treatment was often referred to as
microwave hyperthermia, the Panel has understood the treatments referred to in this
allegation were 434 Mghz treatment and local hyperthermia treatments. The treatment
sheets completed by OncoCare Clinic for Ms ST and Dr Traill’s evidence indicate that
she received those two treatments.91
In his evidence in chief Dr Traill agreed that he recommended local hyperthermia for Ms
ST92. In a letter addressed to Ms ST’s surgeon dated 29 March 200193, Dr Traill said:
I did offer a course of chemotherapy to [Ms ST] concomitant with Whole Body
Hyperthermia but she was not at all keen on that option. It was, therefore
suggested that she consider Regional Microwave Energy Therapy and Local
Microwave Therapy to the areas of concern . . .”
Dr Traill’s notes of a consultation with Ms ST on 1 October 2001 include the following
entry “RMWT + GBA, LMWT” which is understood to refer to 434 Mghz treatment plus
the infusion/glucose blocker referred to earlier and local hyperthermia treatment.
Ms ST’s affidavit94 says that she was told by Dr Traill that she was a suitable patient for
treatment and he and Mr Spall recommended treating her with regional (understood to
be 434 Mghz treatment) and local microwave therapy (understood to be local
hyperthermia).
There was no denial at any stage by Dr Traill that the two treatments were
recommended.
On the available evidence the Panel is satisfied that Dr Traill either expressly or impliedly
recommended the two treatments for Ms ST.
This particular is confined to the question of whether or not the 434 Mghz and local
hyperthermia treatments were recommended. The particular does not in any way deal
with the appropriateness of any recommendation or the effectiveness of the treatments.
Given the evidence about the role hyperthermia treatment may have and its potential
value in treatment, in the Panel’s view the fact that a recommendation was made in
relation to the local hyperthermia could not of itself it amount to unprofessional conduct.
The question as to whether the local hyperthermia treatment was effective or unproven
is dealt with in particular 2(b)(iii).
91
Book of Evidence, Tab 49
Transcript p.580
93
Book of Evidence, Tab 52
94
Sworn on 25 November 2004, Book of Evidence, Tab 45
92
50
In the light of the views expressed earlier by the Panel in relation to the lack of
effectiveness of the 434 Mghz treatment (see particular 1(a)(iii)), the Panel does have
concerns about the appropriateness of the recommendation that 434 Mghz treatment be
given to Ms ST. This question will be considered more fully under particular 1(b)(iii)
below.
Consent to 434 Mghz and local hyperthermia treatments and effectiveness of treatments
– Particulars 1(b)(ii) and (iii)
It is convenient to deal with these two matters together.
It is alleged that Dr Traill failed to provide Ms ST with adequate information to obtain her
informed consent to “the treatment”. The latter term is not defined in the Notice by
reference to particular treatments. Given that it is understood by the Panel that
particular1(b)(i) refers to both 434 Mghz and local hyperthermia treatment, it has read
the particular as being concerned with the consent obtained for each of those
treatments.
In her affidavit Ms ST said that she had heard about hyperthermia treatments and
sought referral to the OncoCare Clinic for that treatment. The referral made reference to
her being assessed for “radiowave hyperthermia treatment”.95
Like Ms SO, Ms ST signed a Deed of Acknowledgment Informed Consent and Indemnity
in the same form as that set out under particular 1(a)(ii) above.
In relation to the local hyperthermia, Ms ST’s evidence and the fact that she went to
Germany for further hyperthermia treatment suggest that she was aware of the nature of
the treatment, and that it is more likely than not that she consented to the administration
of a treatment known as hyperthermia. The question for consideration though is whether
she consented to the form of hyperthermia offered by Dr Traill.
Ms ST made reference in her affidavit and her oral evidence to concerns about whether
the machine which was used for the local hyperthermia was working, and this was the
subject of cross examination by Dr Traill. Ms Folan also gave evidence about whether
the machinery was working from time to time. It is not possible for the Panel to
determine whether or not certain machinery was working at certain times. It appeared
that, while Ms ST expected the apparatus to be hot to the touch, that was not in fact how
it worked. If that was correct then it is not surprising that she thought it was not working
when she touched it and found it to be cold.
In the course of re-examining Ms Folan Dr Traill asked her about the approach taken
when regional or local hyperthermia was given. There were questions about how she
checked if patients were feeling too hot or not coping with the heat. There then followed
this exchange:
Dr Traill:
95
“If they had a bit of a feeling that they weren’t getting their [money’s]
worth, you would quite happily, and you had the time, you would give
them the works would you?”
Book of Evidence, Tab 62
51
Ms Folan:
“If they could stay in there for longer yes.”
Dr Traill:
“As far as we were concerned at a medical level, we weren’t fussy
how long they stayed in it provided it would be the limit of tolerance
and you didn’t go above it and burn them, is that right?”
Ms Folan:
“Yes, yes and yes.”96
The evidence from both Dr Traill and Ms Folan was that no thermometry of the type
described earlier was used when hyperthermia treatments were given. In her evidence
Ms Folan said that the use of small disc type thermometers placed on the forehead was
tried with some patients but they tended to slip off when the patient became sweaty.
She said that otherwise no thermometry monitoring was used.97
When questioning Ms Folan, Dr Traill asked a number of questions which amounted to
statements from his own knowledge about the treatment. While they were not given
under oath they indicate how the treatment was delivered. In relation to the local
hyperthermia treatment to be delivered to Ms ST’s right breast Ms Folan confirmed that
there was concern about the mastectomy site getting too hot and Ms ST being burnt and
so the intensity of the heat was turned down on that side.98
It was Professor Peters’ view that, as there was poor control over the hyperthermia
treatment, it was “manifestly ineffective.” In cross examination Professor Peters was
asked what he would do if a patient such as Ms ST had received hyperthermia treatment
up to a certain temperature and said she could not tolerate that heat or conversely that
she could go to a higher temperature. While not agreeing that he would use
hyperthermia for such a patient, Professor Peters said that he would not rely on the
patient’s subjective sensations alone to know what temperature had been received
because that would give no knowledge of what thermal dose had been received. He did
not agree that it would be appropriate to increase the temperature if the patient indicated
that was preferred. He said “I think the specified temperature should be reached and
maintained for the duration of the scheduled treatment, which is usually about an hour,
and then it should be terminated regardless of whether the patient thinks it was hot
enough or too hot or whatever.”99
In her evidence Ms ST said that at the initial consultation Dr Traill referred to the
treatment offered by Dr Holt in Western Australia and she said “So they talked about it
as being a treatment that was used by Dr John Holt and it was experimental and I did
actually know that.” She went on to say in response to a question about whether she
was told it could cure cancer, put it into regression or whether it was to have a palliative
effect: “Well it was intended to be given as an alternative to radiation and more
chemotherapy after surgery and it was intended to replace those particular therapies or
treatments. My understanding was that it was more than palliative, that it would be
effective as I’m sure they hoped it would be effective.”100
96
Transcript pp.254-255
Transcript p.257
98
Transcript p.210
99
Transcript pp.416-418
100
Transcript pp.71-72
97
52
Dr Traill said in his written submission that;
•
•
•
•
He was unaware of any evidence that the 434 Mghz or local hyperthermia
treatments were ineffective or unproven. In relation to the 434 Mghz treatment
he said that it “had been shown to have effects upon other patients (eg [Ms
SO])”;
The pre and post Dr Traill’s treatment photomicrographs, which are understood
to have been obtained from Ms ST’s medical records, “show evidence that the
treatments were effective, in that cell nuclei were smaller, more crowded and
showed more apoptic changes”;
“The biopsy wound did not break down and ulcerate, but healed, consistent with
a beneficial treatment effect.”; and
“The lymphoedema of the skin of the breast abated, consistent with a beneficial
treatment effect”.
No evidence was produced by Dr Traill to show that without the 434 Mghz treatment or
the local hyperthermia the wound was less likely to heal or that the lymphoedema of the
skin would not have abated. When the photomicrographs referred to were presented to
Professor Peters and Dr Drummond, they were each of the view that no conclusions
could be drawn from those records alone.
Professor Peters said that before and after photomicrographs showing morphologic
changes is an entirely different issue from showing clinical benefit. He expressed the
view that the photomicrographs were meaningless in the sense that there is no way of
knowing whether they were taken from the same lesion and it was not known whether
there was trimming of the biopsy specimens. In his view the photomicrographs were
“like an anecdote.”101
Dr Drummond said that, while not a pathologist, she was unable to identify whether the
picture showed breast tissue, connective tissue, muscle or fibrous tissue. She also said
that Dr Traill’s explanation that the local hyperthermia treatment was intended to treat
the cancer in the surface of the skin rather than the deeper structures, represented
breast cancer in a somewhat misleading fashion. She then described how, where there
is a local recurrence in a post-mastectomy setting it is likely that there will also be a
tumour. Accordingly in her view, treatment of a few millimetres into the skin surface,
while appropriate to treat the skin surface, would not necessarily control the tumour. The
Panel understood that, while she agreed that it would be appropriate to avoid ulceration
of the skin, that would only control the symptoms and a failure to treat the deeper tumour
would lead to further local recurrences.102
It is the Panel’s view that, even if Ms ST consented to the administration of a treatment
known as local hyperthermia, it cannot be satisfied that she consented to a treatment
which was given in such a way that there was no way of ascertaining what temperature
was applied, whether it was properly directed to the area of concern and there was no
systematic approach to its delivery supported by an established rationale. There was no
evidence to show that it had a beneficial effect on Ms ST.
101
102
Transcript pp.409-418
Transcript pp.271 - 273
53
Taking into account all of the evidence and for the reasons set out earlier in relation to
Ms SO and particular 1(a)(ii) in relation to the adequacy of the consent obtained, the
Panel is of the view that the consent obtained in relation to the 434 Mghz treatment from
Ms ST was inadequate. This is because the treatment itself in general terms was, in the
Panel’s view, not shown to be effective for any patient and particularly not for Ms ST. It
is also the Panel’s view that the 434 Mghz treatment is ineffective and unproven in
relation to the treatment of Ms ST.
Both particulars 1(b)(ii) and (iii) are made out.
Records of treatment – Particular 1(b)(iv)
On 5 January 2001 Dr Robert Linacre, Ms ST’s surgeon based in Tasmania, wrote to Dr
Traill saying, after referring to Ms ST’s history briefly:
“I think it is important that we maintain normal professional relationships. I
would be very happy to provide you with clinical details, pathology reports or
whatever if that is of any help to you.
I would be most grateful if you could provide me with details of your treatment
protocols and your assessment of [Ms ST’s] progress. I would be very happy
to take a phone call at any time.”103
On 29 March 2001 Dr Traill replied in the form of a 3 page letter which described Ms
ST’s history and the treatment given. The letter also included an apology for the delay in
responding and explained that Dr Linacre’s letter had been mislaid.104
Mr O’Neill submitted that the delay ought to be taken in the context of Dr Traill’s
suspicion that a nodule or pimple on Ms ST’s breast area was a secondary cancer.
Dr Traill contended that, as Dr Linacre was not the referring doctor, he needed to wait
until he had specific authorisation from Ms ST to respond and that was not received until
1 March 2001. He also said that a copy of a letter dated 8 March 2001 was sent to Dr
Linacre. Dr Traill also submitted that there was little additional information he could
impart to Dr Linacre “over that which the patient could tell any doctor herself.”
This latter comment is particularly surprising to the Panel given that Dr Traill maintains
that his treatments had a beneficial effect on Ms ST and, given the complexity of those
treatments and his doubts that the Panel would understand them, he nevertheless
expected that his patient could communicate to another medical practitioner all that he
could.
In his written submission, Dr Traill also relied on the fact that there was no urgency
attached to a diagnosis being made of the skin lesion. He said “The time interval
allowed the clinical picture to unfold, with further secondaries appearing, making the
clinical picture, and the recurrences clearer.” This comment is also somewhat surprising
given that Dr Traill considered that his treatments had a beneficial effect on Ms ST.
103
104
Book of Evidence, Tab 65
Book of Evidence, Tab 52
54
It is the Panel’s view that the response given to Dr Linacre was not timely, even leaving
aside the question of whether there was an urgent need for further review and possible
biopsy. In the circumstances of a patient with Ms ST’s history being treated by a medical
practitioner who has identified possible secondary cancers (discussed below), it is the
Panel’s view that it is appropriate for communication to be made promptly on request.
While it may be that the delay of 3 months did no harm to Ms ST, it was not conducive to
allowing her treating practitioners to fully understand the treatments she had undergone
to assist them in planning.
In the Panel’s view the particular is made out.
Skin lesions – Allegations 1(b)(v) and (vi)
During the course of the hearing and particularly the cross examination of Ms ST, there
were lengthy discussions and exchanges about the location, appearance and size of the
skin lesion referred to in the particular. In the Panel’s view that evidence was largely
irrelevant, as Dr Traill’s own notes confirm that there was a lesion and that he was aware
of it.105 The relevant words were recorded on 23 January 2001 and say “Has small
nodule on scar at posteria end. ? Secondary ? Suture”
In the course of questioning Professor Peters about the skin lesion, Dr Traill said:
“Anyway she then did [develop, I] observed some spots in the skin which were
subsequently – well she showed one to me. It was in, I can’t remember the date, but
when she was seeing me and I actually wrote in the file query secondary . . . I thought it
was a secondary at that stage, a secondary cancer.”106 While these statements were not
made under oath they confirm the fact that the existence of the lesion was known to Dr
Traill at the time he was treating Ms ST and that he considered whether it indicated
secondary cancers. At no stage was that knowledge denied.
The significant question which arises under these particulars is whether Dr Traill
responded appropriately to the existence of the lesion in the context of his concerns.
Mr O’Neill asked Dr Drummond whether she would be concerned about a patient with
Ms ST’s history presenting with a small red pimple like dot approximately 2 millimeters in
diameter 7 centimeters below the mastectomy incision line. Her response was that any
kind of reappearance in the mastectomy area would be of concern and there would be
immediate suspicion of recurrent tumour.107
Dr Traill asked further questions about this matter. Dr Drummond said that any skin
change in the skin post mastectomy would be regarded as suspicious and that she
would want to exclude the possibility that it is cancer. She said in her experience that
post mastectomy the skin can be highly variable and that, what is initially thought to be a
dermatitis or a minor infection, not infrequently turns out to be cancer. It was her view
that it was necessary to establish which diagnosis was correct. Dr Traill then asked
whether there was a sense of urgency about such a skin change. She said that, while a
local recurrence would not be life threatening, in terms of managing the patient’s care
and symptoms and to give the best possibility of treatment, early diagnosis via a biopsy
105
Book of Evidence, Tab 60
Transcript p.413
107
Transcript pp.280-281
106
55
would be an advantage. In terms of urgency she said that it would depend on the
circumstances and that a matter of a few weeks would not be significant in many cases if
there was not a big change in that time. She also commented that the urgency tended
to come from the patient’s concerns.108
Professor Peters’ view was that it was important that a biopsy be obtained.109
In cross examination Dr Traill agreed with the proposition that any lump, pimple or
reddened area on the skin in Ms ST’s case would be a clear indicator that there was a
risk of a recurrence of the cancer. Dr Traill’s position was that it was not necessary at
that time to obtain a biopsy despite this view. He explained that the reasons in this case
for not doing a biopsy included the possibility that it could lead to a spread of the cancer
and more importantly that it could create a non healing malignant ulcer. He also referred
to the possibility that the nodule had resulted from the Eurixor injections which had been
administered to Ms ST. He also said that he expected that Ms ST would return to her
doctors in Tasmania and they could handle the biopsy.110 Mr O’Neill described these
explanations as “inconsistent and unbelievable.”
While the Panel is satisfied that both particulars are made out as a question of fact, it
would not conclude that the failures amounted to unprofessional conduct. This view has
been reached taking into account:
•
•
•
The fact that Dr Traill was offering only limited forms of treatment to Ms ST and
had not taken over her care;
The evidence of Dr Drummond that it was not a matter of clinical urgency to
conduct a biopsy; and
Importantly the fact that Ms ST’s treating doctors did not perform a biopsy until
March 2001.
While not the subject of the particular, the Panel considers that it would have been
prudent for Dr Traill to have recommended to Ms ST that she seek advice from her
treating practitioners before continuing with the treatment he offered. In this context it
may be noted that Dr Traill said in evidence that he did not tell Ms ST of his concerns
about possible secondaries and that instead he told her to wait and see.111
Treatment charges – Particular 1(b)(vii)
The material before the Panel indicated that the amount of $10,734.85 related to
consultations, the 434 Mghz treatments, the local hyperthermia treatments and the
administration of drugs under HIC item number 13915.112 The last of these will be dealt
with in the discussion of particular 1(b)(viii).
Dr Traill argued that Ms ST’s willingness to expend a greater amount of funds seeking
treatment in Germany indicated that the amount he had charged was not excessive. In
the Panel’s view, Ms ST’s willingness to pursue conventional or other non conventional
108
Transcript pp.281-283
Transcript p. 432
110
Transcript pp.681-689
111
Transcript pp.589-590
112
See Exhibit RJH-4 to Ms ST’s affidavit sworn 25 November 2004, Book of Evidence, Tab 45
109
56
forms of treatment is not necessarily relevant to the question of whether the specific
charge levied by Dr Traill was excessive for the treatments given. As discussed in the
context of Ms SO and particular1(a)(vii), the amount charged must be regarded as
excessive as we have concluded that they were of no beneficial effect to Ms ST and she
is not considered to have given informed consent to the treatments which led to those
costs being incurred.
The particular is made out.
Health Insurance Commission Charges – Particular 1(b)(viii)
The question of the substance administered by Dr Traill under HIC item number 13915
has been discussed above under particular 1(a)(iv).
Ms ST’s evidence was that she was told that the substance which was being injected
was to enhance the hyperthermia (understood to refer to the 434 Mghz treatment). She
also said that she understood that that the substance was not chemotherapy because
she had been expressly told that she was not suited to more chemotherapy and that she
may have developed a chemical sensitivity to chemotherapy. Ms ST was asked whether
the substance was cytotoxic and whether she understood that term. Ms ST replied that
it was not, that she did understand the term “cytotoxic” and was familiar with a number of
chemotherapeutic drugs. She also said that she was aware from her own experience of
the effect on the body of chemotherapeutic drugs. Ms ST indicated that the substance
did not have those effects and was not given in the manner in which chemotherapy is
usually given, again from her own experience. Ms ST said that she believed that the
substance was glucose based.113
The treatment sheet for Ms ST also included a column for details of chemotherapy to be
set out and, as in the case of Ms SO, it was blank.114
In his written submission concerning Ms ST, Dr Traill said that the same type of
substance had been used for many years by Dr Holt and had been charged under the
same item number and that amounted to a precedent. In the Panel’s view the fact that
another practitioner has taken the same approach to billing on an item number cannot of
itself make it correct.
For the reasons expressed earlier, it is the view of the Panel that the substance
administered by Dr Traill to Ms ST cannot fairly be described as cytotoxic chemotherapy
and so the billing of that substance under HIC item number 13915 was inappropriate.
The particular is made out.
Allegation concerning Master TU
Recommendation of 434 Mghz Treatment – Particular 1(c)(i)
As indicated earlier, Master TU attended the OncoCare Clinic between 9 October and on
or around 1 November 2001.
113
114
Transcript p.73, pp.195-197
Book of Evidence, Tab 49
57
In a letter dated 16 October 2001 to the referring doctor, Dr Traill said:
“After a lengthy discussion with [Master TU’s] parents, it was decided that
[Master TU] would commence 10 sessions of Regional Microwave
Hyperthermia at a special discount rate.
The experience of Dr John Holt in Western Australia is that Microwave
Treatment using his protocols can have quite a gratifying effect upon brain
tumours. My experience to date is in agreement.”115
The Panel understands that the treatment Dr Traill was referring to was the 434 Mghz
treatment.
Dr Traill’s notes include an entry for 11 October 2001 which includes the words: “Wants
to do something. Options outlined.”116
On that day Master TU’s mother executed a Deed of Acknowledgment Informed Consent
and Indemnity which was in the same form as those executed by Ms SO and Ms ST.
The 434 Mghz treatment commenced on that day also.
Master TU’s treating doctors were Dr DD and Dr Peter Downie. His condition was
described as anaplastic ependymoma which is a highly malignant and progressive brain
tumour. In his affidavit117 Dr DD said that after a period of involvement it became
apparent that Master TU’s condition would not respond to conventional treatment with
radiotherapy and surgery and in his best interests palliation became the primary focus.
Dr Downie said in his affidavit118 that he had explained to Master TU’s parents that
neither chemotherapy or radiotherapy were curative treatments but they were aimed at
improving the duration and quality of their son’s life. It was intended that chemotherapy
commence in or around June/July 2001 but instead he was taken to Sydney for surgery
as described earlier and then he commenced treatment with Dr Traill.
In his evidence before the Panel Dr DD described his experience with paediatric cancer
and stated that he had an involvement with all of the children with brain cancer in
Victoria either as a clinician or a consultant. He also said that he would only see 1 child
each year or every 2 years with a tumour like that of Master TU. He later said in
response to questions from Dr Traill that he did not consider that Dr Traill should have
been providing care to a patient such as Master TU because he was not a qualified
medical oncologist or a paediatric oncologist and that the 434 Mghz treatment or any
other treatment should not have been provided to Master TU by any practitioner when
the condition was totally outside their field of training and expertise. 119
Dr Downie also gave evidence in the form of an affidavit and before the Panel. He
confirmed that when he met with Master TU’s parents he explained that, because of the
nature of the condition Master TU’s life expectancy was not particularly long, that he was
likely to die from the condition and that treatment in the form of chemotherapy and
115
Exhibit E
Exhibit E
117
Affirmed on 25 August 2004, Book of Evidence, Tab 67
118
Affirmed on 19 April 2005, Book of Evidence, Tab 99
119
Transcript pp.455-473
116
58
radiation therapy could be given in order to improve the quality of Master TU’s life rather
than to prolong his life. He also confirmed that no treatment, including surgery, could, in
his view, cure the condition. As at October/November 2001 Dr Downie described Master
TU as being physically disabled by the condition and largely unable to walk or talk
clearly. He said that when he saw Master TU again on 8 November 2001 he was much
more disabled and closer to death. His notes said that there was an overall deterioration
neurologically since the last examination. At that time he had a brief consultation with
Master TU’s parents and all that he could say was that they should prepare for his
imminent death.120
In his affidavit Dr Downie said: “While I cannot conclude that Dr Traill’s involvement
shortened [Master TU’S] life, it may have, and given the lack of efficacy in the treatment,
it did not lengthen his life or improve the quality of his life.”
Professor Peters evidence was that, as Master TU was “pre-terminal”, giving him 434
MHz treatment was inappropriate “Because he was about to die, and the fact of the
matter was that no intervention of any type could have saved him at that point.”121
In his written submission Dr Traill said:
•
•
•
•
•
The 434 Mghz treatment has been reported to be effective in cases of malignant
brain tumours known as gliomas. Malignant ependymoma is a malignant glioma
and the treatment was “likely to be effective”;
The family were not seeking palliative care;
The patient was referred for the treatment and not to take over the ongoing care;
The radiotherapy administered was more destructive and damaging that the 434
Mghz treatment, required disfiguring dexamethasone treatment, was more
intrusive in the day to day lives of the family than the 434 Mghz treatment and
offered more false hopes than the 434 Mghz treatment; and
The radiotherapy was “close to barbaric for a dying child, and the MPB should be
concerned that it had been administered.”
In a letter to the Board dated 11 December 2002122 Dr Traill said that in giving 434 Mghz
treatment to Master TU “No cure was ever entertained or promised. The aim was to
treat the patient (not the disease) in a way which may alleviate symptoms and possibly
prolong life.” (Dr Traill’s emphasis). The letter also said that the treatment was of an
adjunctive type.
Dr Traill said that the treatment was sought by Master TU’s parents in the 6 week period
between deep x-ray therapy and a scheduled MRI as the parents felt that “more could be
done in the interim for a temporary stay for his incurable disease . . . The parents were in
no doubt of the dismal prognosis. The hospital was not seen to be providing the
additional assistance.”
In his evidence in chief Dr Traill said, “I have reason to believe that it probably had an
effect and nobody else has proved evidence to the contrary.”123
120
Transcript pp.124-125; 128-129, Master TU’s medical records
Transcript p. 433
122
Book of Evidence, Tab 75
123
Transcript p.594
121
59
Under cross-examination, Dr Traill said that he told Master TU’s parents, at least via the
Deed of Consent, that the treatment “can have some improvement on survival”. He was
asked if Master TU’s life was prolonged as a result of the 434 Mghz treatment and he
said in response:
“Well it wouldn’t have been by much, he was pretty far gone when we saw him
anyway. It was . . . prognosis was not good, but the parents wanted it and we
went through with the ramifications and their aim was to try and get him to see
this sort of thrill park . . . and we hoped to assist in that.”
Dr Traill was then asked whether he could provide any scientifically based evidence
which would indicate that Master TU’s life was prolonged. He said, “Well I can’t prove if
it prolonged his life.” He was asked why then he had said in other material before the
Panel that it had done so. Dr Traill’s response was “I believe it may have. I don’t think I
used a definite word did I?”124
Dr DD gave evidence to the effect that narcotic and other measures could have been
established to try to keep Master TU headache and symptom free to allow him to travel
by air and visit the theme park to which Dr Traill referred.125
In cross examination Dr Traill was asked whether he had any experience in treating an
anaplastic ependymoma and the response was that he had not. Dr Traill also said, after
stating the referral had been for the 434 Mghz treatment, “ . . .they wanted the treatment
and we gave it to them.” He went on to say: “By and large we take the cue from the
patient, or in this case the parent’s wish. . . . Yes, there might have been proposed
treatments in the palliative care, psychological type, but we didn’t interfere with that, and
in fact it was probably that they felt that they were doing something, it was probably part
of the adjustment process to accepting that they had a child with an incurable cancer.”
When reference was made to the word “recommended” in the particular, Dr Traill said
that was not quite the word he would have used.126
Dr Traill took the view that the treatment he gave was no more disruptive to Master TU
and his family than the treatments proposed by Dr DD and Dr Downie. When
questioning Dr Downie he said: “The treatments by the way are no more traumatic than
say a patient putting a head in to a hairdryer at a hairdressing salon, you know those
female hair driers, although it’s on a grander scale, but it’s no more traumatic than doing
that.” Dr Traill then referred to the length of time of the treatments and the travel and
suggested it was not likely to interfere with other treatments. Dr Downie’s response was
that the family also could have been at home.127
It was noted by Dr DD that had the described palliative treatment been given to Master
TU at the RCH, accommodation would have been available to the family so they would
not have been required to travel each day from their home in Warragul.128
124
Transcript p.704
Transcript p.477
126
Transcript pp.696-701
127
Transcript pp.145-146
128
Transcript p.468
125
60
The evidence of Dr Downie, supported by Master TU’s medical records, indicated that as
at early August 2001 there had been a slight improvement in Master TU’s condition after
he had commenced radiation therapy as he had started to walk. The next review was on
8 November a few days after the last 434 Mghz treatment and, as described earlier, Dr
Downie said that he recalled Master TU looked worse. His notes stated that an MRI was
required so that further information could be given to his parents. A subsequent scan
showed that the disease had progressed.129 As stated earlier Master TU died on 1
December 2001.
It is the Panel’s view that, in the circumstances faced by Master TU’s parents and Dr
Traill’s willingness to offer the 434 Mghz treatment which he believed might help Master
TU’s condition, whether in a treating or palliative sense, it can be said he recommended
that treatment.
Taking into account the earlier conclusions drawn by the Panel regarding the
effectiveness of 434 Mghz treatment and the clinical decline of Master TU, the Panel is
of the view that the treatment given by Dr Traill was entirely inappropriate for Master
TU’s condition and was not efficacious.
The particular is made out.
The Panel notes that, while it is aware that Dr Traill had concerns about the radiotherapy
and other treatments given to Master TU, it is not a matter about which this Panel is
empowered to consider or to comment.
Interference with treatment and management – Particulars 1(c)(ii) and (iii)
Dr DD and Dr Downie both considered that the treatment given by Dr Traill interfered
with the treating relationship between themselves and Master TU’s parents and also the
clinical management of Master TU.
There were two aspects to the interference which they considered had occurred. Firstly,
the planned chemotherapy and radiotherapy did not proceed after Master TU returned
from Sydney, and secondly the holistic approach to the care of Master TU and his family
was not able to be implemented.
The significance of the treating relationship and what was available was described in the
following way to the Panel by Dr DD:
“We have a multi-disciplinary team of physicians and allied health professionals
who provide comprehensive care to families. The difficulty, as you can
imagine, for a family of a young child that face such [a] disastrous outcome are
coming to grips psychologically with what I would say is nature upside down, to
contemplate the thought of your child dying before you do as a parent is almost
unbearable and the way that services for palliation are organised in our
community, it does require families to overcome that psychological hurdle to
some extent and we – the multi-disciplinary team of professionals works very
hard at the Children’s’ Hospital to help families through this terrible journey and
129
Transcript pp.148-150
61
to get appropriate palliative services in to the home to care for the physical and
emotional needs both of the child and the family.”
He also said:
“The difficulty is if the family haven’t reached the point in their emotional
journey to accept that care, because they don’t believe their child’s dying, then
you can’t implement it, because they simply won’t allow you in. And that –
that’s fundamentally why I believe that – and it was of concern to me that there
had the potential for interference between this relationship.”130
The team referred to was said to include physicians, the director of the RCH’s palliative
care team, nurse care coordinators or specialist nurses, social workers, psychologists,
physiotherapists and occupational therapists.
Dr Downie’s evidence was similar and in his affidavit he said that, although some nursing
and allied staff support was delivered, it was not coordinated by the RCH, as would have
been the case had the family been in a therapeutic relationship with him rather than Dr
Traill.
Dr Downie said in his evidence in chief:
“ . . I think that this was a family where they were always looking for something
else because of what had been told to them at the beginning. And it’s never
our place to put ourselves in families shoes, but if you can imagine what it
would be like to have a child that is disabled and dying and any sort of hope if
you will that’s given out will be grasped at, and I have no doubt that that’s what
happened with the surgery . . . And they were a family that were really seeking
constantly something else other than what we were able to offer them from a
medical point of view. But my opinion is that that was false because there is
nothing that I am aware of that was going to cure this boy.”131
It was his view that the involvement of Dr Traill meant that the family did not engage with
he and the RCH.
As indicated above, Dr Traill said that his recollection was that the family felt that the
RCH was not doing enough. He said in correspondence to the Board and at the hearing
that he understood that the family wanted to gain some additional time so that they could
all make a trip together to Queensland. This was also Ms Folan’s evidence. He also
said that Master TU’s parents indicated that, before hearing about him, they intended to
go to Western Australia to see Dr Holt.132
The question raised by these two particulars is a difficult one, particularly as no evidence
was available from Master TU’s parents as to their understandings, intentions or
motivations. On the one hand the statements made by Dr DD and Dr Downie are
130
Transcript pp. 458-459
Transcript pp.128-129
132
Transcript p.700; Ms Folan’s affidavit, Book of Evidence, Tab 109; Handwritten note of Master TU’s
parents, Book of Evidence, Tab 116
131
62
compelling in relation to the need for a strong relationship to be developed and
maintained between the family of a child such as Master TU and the treating physicians.
On the other hand it appears correct to say that Master TU’s parents made decisions on
more than one occasion to seek treatment or advice away from the care of the primary
treating physicians. The unsuccessful trip to Sydney indicates that they wanted to take
advantage of any possibility which could help their son to recover or have a prolonged
life. They were well entitled to make such a decision.
It seems to the Panel that the cause of the apparent decision by Master TU’s parents not
to have chemotherapy and other treatment in or around October/November 2001 and
not to have the holistic care from the RCH was based on their own assessment about
how to deal with their son’s condition. It does not seem that the cause was the offer of
treatment by Dr Traill. It would appear that, had Dr Traill refused to treat Master TU,
they would have considered travelling to Western Australia for the same or similar
treatment. Having said that, it does seem likely that the offer of treatment was expected
or at least hoped by Master TU’s parents to bring some positive result and this must
have impacted on their decisions.
This view appears to be supported by Dr Downie’s agreement with a proposition put by
the Panel to the effect that the family of Master TU would have been very difficult to
engage in palliative care because they were always looking for a treatment that would
offer hope.133
The particulars are not made out.
Contact with treating oncologist – Particular 1(c)(iv)
It was not disputed that Dr Traill made no contact with Dr Downie. As referred to earlier,
he did send the letter dated 16 October 2001 to Master TU’s referring doctor. During the
course of cross examination Dr Downie said that he was aware that Master TU was
being treated by Dr Traill and he agreed with Dr Traill’s suggestion that the information
about that probably came from the referring doctor.134
Mr O’Neill submitted that, in circumstances where Dr Traill was inexperienced in treating
the particular condition and he knew of the involvement of the team at the RCH, he
ought to have sought details of the earlier treatment and advised of the treatment he
intended to undertake. Mr O’Neill considered that the failure to communicate with the
RCH and doctors seemed “extraordinary”.
In response Dr Traill submitted that there was no obligation to consult with the oncologist
because Master TU was not being actively treated at the time. He also argued that, as
the treatment was adjunctive and safe, there were no significant risks attached to it being
given alone or in conjunction with other treatments. Dr Traill referred to confidentiality
concerns and the fact that he had not been authorised by Master TU’s parents to
communicate with Dr Downie or others at the RCH. Dr Traill considered that Master
TU’s parents, like Ms ST, could have provided the same information he could have to the
other physicians.
133
134
Transcript p.154
Transcript pp.140-141
63
It is clear that as a question of fact the particular is made out. However, in the Panel’s
view, because Master TU’s parents had sought the treatment and thereby made it known
to the referring doctor and apparently the treating physicians, there was no
unprofessional conduct in Dr Traill failing to initiate contact with Dr Downie or other
physicians at the RCH.
Summary of findings on particulars
In summary the Panel found that:
1.
In relation to allegation 1(a) regarding Ms SO, all particulars were made out as a
question of fact with the exception of particulars (vi) (viii), (x) in relation to CT
scans and x-rays and (xi);
2.
In relation to allegation 1(b) regarding Ms ST, all particulars were made out as a
question of fact. While particulars 1(b)(v) and (vi) were found to be made out as
a question of fact, the Panel was of the view that they could not of themselves
result in a finding of unprofessional conduct; and
3.
In relation to allegation 1(c) regarding Master TU, particulars (i) and (iv) were
made out as a question of fact but particulars (ii) and (iii) were not. While
particular 1(b)(iv) was found to be made out as a question of fact, the Panel was
of the view that the conduct described did not amount to unprofessional conduct
given the circumstances of the case.
Unprofessional conduct
Having satisfied itself that certain particulars have been made out it is the task of the
Panel to decide whether any of the conduct amounts to unprofessional conduct as
defined under the Act.
Definitions of unprofessional conduct
It is well understood that whether or not conduct is unprofessional in the sense of the
definitions contained in section 3(1) sub-paragraphs (a) and (b) of the Act is a matter of
common sense, taking into account the experience of the Panel. The same comment
may be made in relation to the definition in sub-paragraph (e) which deals with the
provision of health services which are excessive, unnecessary or not reasonably
required.
In his written submission Mr O’Neill said that professional misconduct (sub-paragraph (c)
of the definition of unprofessional conduct in section 3(1)) has the following elements:
•
•
•
•
•
It need not be a legal offence;
It is a grave impropriety affecting professional character;
It is judged against the rules and standards of the profession;
It is conduct which other professionals of good repute regard as disgraceful or
dishonourable;
It is a breach of a standard of common decency and common fairness
64
•
•
•
•
•
It can be a persistent breach of a rule or convention that is in the profession;
It does not always result in deregistration;
It can be found when the professional lies or does not show complete honesty
and candour, especially before a disciplinary body;
A novel practice is only misconduct if it attracts professional reprobation not
attributable solely to conservative opinions. Mr O’Neill also referred the Panel to
the decision in Childs v Walton135 on the question of practices adopted by
minority schools and which are innovative; and
Relying on Richter v Walker136, the gravamen of misconduct is breach of trust,
misuse of power and exploitation of vulnerability.
The Panel also had regard to the decision of Kirby P in Pillai v Messiter [No. 2]137 who
said:
“Departures from elementary and generally accepted standards, of
which a medical practitioner could scarcely be heard to say that he
or she was ignorant could amount to such professional misconduct
. . . But the statutory test is not met by mere professional
incompetence or by deficiencies in the practice of the profession.
Something more is required. It includes a deliberate departure
from accepted standards or such serious negligence as, although
not deliberate, to portray indifference and an abuse of the
privileges which accompany registration as a medical practitioner .
..”
Mr O’Neill also provided submissions as to the meaning of infamous conduct in a
professional respect under sub-paragraph (d) of the definition of “unprofessional
conduct”. He said such conduct was, like professional misconduct, also regarded as
disgraceful or dishonourable by professional colleagues of good repute and competency
, referring to Allinson v General Council of Medical Education and Registration .138
Lopez LJ said in Allinson:
"If it is shewn that a medical man, in the pursuit of his profession, has done
something with regard to it which would be reasonably regarded as disgraceful
and dishonourable by his professional brethren of good repute and competency,
then it is open for the General Medical Council to say that he has been guilty of
‘infamous conduct in a professional respect’."
It is not necessary for the conduct to be “wicked, vile or evil”.139
In Basser v The Medical Board of Victoria, O’Bryan J said140:
135
Unreported, 13 November 1990, NSW Court of Appeal
Unreported, NSW Court of Appeal, 15 June 1993 per Kirby P, Priestly JA and O’Keefe AJA
137
(1989) 16 NSWLR 197 at 200
138
[1894] 1 QB 750
139
Hartnett v The Medical Board of Victoria [1941] VLR 289
140
[1981] VR 953 at 968
136
65
“1.
Infamous conduct may be proved if a medical practitioner in the course
of conducting his medical practice is shown to have acted with reckless
indifference to the possible harmful consequences of his acts. It would
be necessary to show that the medical practitioner realised the possible
harmful consequences of his acts and was recklessly indifferent to their
consequences.
2.
Infamous conduct may be proved is a medical practitioner in the course
of conducting his medical practice is shown to have acted with a high
degree of negligence amounting to gross incompetence.
3.
In cases in which ‘reckless indifference’ or ‘a high degree of negligence’
is alleged, it will also be necessary to prove that right-thinking
competent medical practitioners would regard the acts of the person
charged as reprehensible, disgraceful, shameful or dishonourable. This
may be inferred from all the circumstances.”
The Panel was aware that a finding of infamous conduct in a professional respect is
regarded as the most serious finding open to it.
Dr Traill denied the allegations and made no submissions as to the meaning to be given
to the relevant definitions of unprofessional conduct.
Panel’s Findings
In reaching findings on the allegations of unprofessional conduct, the Panel has
considered the proven particulars and the common points in Dr Traill’s conduct which it
sees as:
•
•
•
•
•
•
The recommendation and administration of unproven and ineffective treatments,
namely full body and local hyperthermia, 434 Mghz and lithium;
The inadequacies associated with the consents obtained for the treatments given
to Ms SO and Ms ST;
The charges to the HIC for so called chemotherapy in relation to Ms SO and Ms
ST;
The excessive charging for the treatments to Ms SO and Ms ST;
The fact that Dr Traill represented himself to be an oncologist to Ms SO and
maintained that position in the hearing; and
The inadequate management and monitoring of patients with serious conditions.
This included the apparently experimental monitoring of uric acid in the case of
Ms SO.
As is apparent from the reasons dealing with the particulars, the Panel is critical of Dr
Traill in relation to each of these matters. As the Panel considers that the treatments
offered were ineffective and not beneficial, in its view it was necessary for Dr Traill to
exercise extreme caution when offering those treatments. In the Panel’s view it was
necessary for him to ensure he had obtained fully informed consent to the precise
treatments, including how he administered them, and for him to ensure that the patients
were fully aware of his own views about the preferred treatment for their conditions and
66
the conventional treatments available to them from other practitioners. It was clear that
Dr Traill did not do this in relation to Ms SO and the Panel did not regard the statements
in his patient information documents and Deed of Acknowledgement and Consent to be
adequate in relation to the other patients.
In addition, the Panel considers it was incumbent on Dr Traill to ensure that he was
satisfied that the treatments would have a beneficial effect for the patients. As has been
detailed in these reasons it was apparent to the Panel that:
•
•
•
•
While Dr Traill strongly believes that the 434 Mghz treatment has an effect on
cancer tumours even he cannot fully explain how this is so or show that there is
an effect. Despite being aware of the usual way in which new or novel
treatments are tested, Dr Traill offered the treatments and charged for them
without publishing any scientific or appropriately conducted clinical trials for
review by his peers;
At least in relation to Ms SO, his strategy was that he intended to give her a
treatment he knew to be ineffective (the whole body hyperthermia without
chemotherapy) in order to persuade her to agree to chemotherapy later. He did
not explain this to Ms SO and his evidence about this matter suggested that,
while he may have had good intentions, he regarded it as acceptable to
manipulate patients into treatments;
Dr Traill considered all patients were responsible for the selection of treatments
and so they were responsible for any resulting impact. This attitude failed to take
into account the fact that, as the medical practitioner, he was best placed to know
whether the treatment was likely to be appropriate. Dr Traill’s comments about
the condition of Ms ST and Master TU and the usefulness of the treatment for
them set out earlier seemed to the Panel to suggest recklessness; and
On a number of occasions Dr Traill indicated that he believed that, if patients
wished to be treated, it was appropriate that he offer that treatment irrespective of
its clinical benefit.
Dr Traill said in his submission that the patients “were not especially vulnerable”, were
given adequate information about his treatments and were not locked into contracts.
This seemed to the Panel to show that Dr Traill lacked insight into the special needs of
patients such as Ms SO, Ms ST and Master TU. Taken with the facts that the treatments
as given were not just novel but effectively experimental and the substantial amounts
were charged for them, the Panel considered Dr Traill’s conduct to be especially
blameworthy.
While it is not a matter for the Panel to reach a view about whether the charges to the
HIC amounted to fraud, it considered Dr Traill’s evidence as to his beliefs about this
matter to be questionable.
As is clear from these comments and the discussion in these reasons, the Panel
considers that Dr Traill engaged in unprofessional conduct in relation to each patient in
the sense that his conduct was of a lesser standard than that which is reasonably
expected of a registered medical practitioner by the public and his peers (subparagraphs (a) and (b) of the definition of unprofessional conduct in section 3(1) of the
Act).
67
It ought also be apparent from these reasons that the Panel has found that Dr Traill
engaged in unprofessional conduct as described in sub-paragraph (e) of the definition of
unprofessional conduct in section 3(1) of the Act in that he provided health services
which were excessive, unnecessary or not reasonably required for each patient.
The Panel also considers that the conduct described amounts to professional
misconduct in a professional respect as described by Mr O’Neill. It considers that, to use
the words from Pillai v Messiter [No 2], Dr Traill’s conduct amounted to a deliberate
departure from accepted standards and it did in the Panel’s view portray indifference and
an abuse of the privileges which accompany registration. Dr Traill's conduct amounts to
unprofessional conduct as defined under sub-paragraph (c) of the definition of
unprofessional conduct in section 3(1) of the Act.
While the Panel considered that the conduct came very close to amounting to infamous
conduct in a professional respect as discussed in the cases, it concluded that it fell just
short of that level.
Having determined that Dr Traill engaged in unprofessional conduct, the Panel
considered whether it was of a serious nature under section 45A of the Act and
concluded that, given the views expressed in the reasons, the unprofessional conduct
was of a serious nature. In the Panel’s view it is clearly conduct which is not trivial or of
momentary effect. It is blameworthy and is a departure in a substantial manner from the
standards expected of a medical practitioner.141
The formal Findings of the Panel are that:
1.
Dr Traill engaged in unprofessional conduct within the meaning of paragraphs
3(1)(a) and/or 3(1)(b) and/or 3(1)(c) and/or 3(1)(e) of the definition of
"unprofessional conduct" in the Act, in that during the period on or about 23
September 2000 to 27 November 2000, he failed to exercise the care and skill of
a competent medical practitioner in his treatment of his patient, Ms SO, who was
diagnosed in August 2000 with small cell carcinoma of the lung;
2.
Dr Traill engaged in unprofessional conduct within the meaning of paragraphs
3(1)(a) and/or 3(1)(b) and/or 3(1)(c) and/or 3(1)(e) of the definition of
"unprofessional conduct" in the Act, in that between 22 January and 9 February
2001, he failed to exercise the care and skill of a competent medical practitioner
in his treatment of his patient, Ms ST, who suffered from recurrent cutaneous
metastatic breast cancer of the right breast; and
3.
Dr Traill engaged in unprofessional conduct within the meaning of paragraphs
3(1)(a) and/or 3(1)(b) and/or 3(1)(c) and/or 3(1)(e) of the definition of
"unprofessional conduct" in the Act, in that during the period on or about October
and November 2001, he failed to exercise the care and skill of a competent
medical practitioner in his treatment of his patient, Master TU, a five-year-old
child with a malignant brain tumour, a widely disseminated anaplastic
ependymoma; and
141
Parr v Nurses Board of Victoria (1998) 16 VAR 118
68
4.
That unprofessional conduct was of a serious nature pursuant to section
45A(1)(a) of the Act.
Determination
Submissions as to Determination
Mr O’Neill drew the Panel’s attention to the fact that its role is to protect the public,
maintain standards and the reputation of the profession and also that any Determination
is not intended to punish or bring retribution on Dr Traill.
In the light of the Findings of the Panel, Mr O’Neill submitted that the Panel ought to
consider suspension or cancellation of Dr Traill’s registration. Mr O’Neill drew the
Panel’s attention to an earlier occasion when Dr Traill had come before a Panel in a
Formal Hearing and briefly outlined those circumstances which concerned charging for
services under the Health Insurance Act 1973 (Cth) which occurred some 10 years ago.
He submitted that the Panel ought not to attach great significance to that matter.142
Dr Traill was asked if he would like an adjournment to prepare submissions but he
elected to proceed. He expressed surprise at the Findings and commented upon them.
He said that he was now semi-retired and was not currently treating any cancer patients.
He also said that he was clearly no longer practicing in the areas which were the subject
of the Notice.
He explained that a cure was never promised to the patients and that patients were told
that he believed that the treatments could slow tumour growth. He said: “I believe that I
tried – I did best endeavours to establish the position of this form of treatment and I gave
it to patients in a way in which I believed at the time and I believe subsequently never
harmed them.”
He said, given he was in semi-retirement and was seeing patients who were not
“remarkable”, that deregistration or even temporary cancellation is “a little harsh and
unnecessary considering the background and I believe that I took due care of the
patients at the time.” He went on: “You may think I was misguided and made a bad
judgment well so be it. But that’s history now and we have to learn by history.”143
The Panel asked questions of Dr Traill about his current practice. He indicated that,
while he had not been able to access Medicare as a result of a decision of the HIC in the
case referred to earlier for a period of three years (ending in September 2005), he had
continued to practice throughout that period. He said that he had around 20 patients
and he was acting as a specialist clinician. He said most of his patients were referred to
him by general practitioners. He said his work included patients with WorkCover related
claims, victims of crime and patients who required pain management. He also referred
to patients with type 2 diabetes and a patient with myesthesia gravis.
When asked why he gave up work at the OncoCare Clinic, Dr Traill said that it was
because there were insufficient patients and so insufficient funds to continue.
142
143
Transcript pp.750-754
Transcript pp.755-759
69
Dr Traill was asked if he was currently offering what may be described as
unconventional treatments at present. His response was: “It all depends who you talk to
of course.” He was then asked if he was, for example, treating patients with multiple
sclerosis with lithium. He said the patient who he had so treated had moved away.
In explaining why patients are prepared to see him despite not being able to make
claims on Medicare, Dr Traill explained: “I am a specialist. I’m a specialist in aspects of
disease and the treatment which means that I’m in a better position to investigate, initiate
treatments and follow up treatments than many other practitioners.” He went on to say
that the patients referred to him often had conditions which require pathology tests.
He said he was practicing from home and had approximately ten hours per week of
patient contact. When asked whether he complied with the requirements of the College
of Pathologists’ continuing education requirements, Dr Traill said he did although he
described them as rather vague and as amounting to a “do it yourself arrangement.” 144
The Panel was provided with copies of testimonials which had been made available in
the earlier Formal Hearing. Those testimonials were from various patients who
expressed their confidence and gratitude for Dr Traill’s treatment and attention over, in
some cases, many years. No further character evidence was called by Dr Traill although
he was informed by Mr O’Neill that he could seek an adjournment to do so.
Law relevant to determination
As stated by Mr O’Neill, when considering what determination is appropriate the Panel
has been mindful that its role is to protect the public.145
The Panel has taken into account the discussion in Craig v The Medical Board of South
Australia to the effect that the public interest in the practitioner continuing to practice
must be weighed against the public interest in protecting patients from any repetition of
the conduct exhibited in any case and in particular the following passage:
“ . . sometimes the protection of the public will require the making
of an order with a greater adverse effect on the practitioner than
might be warranted if punishment alone were the relevant
consideration . . . In other cases the protection of the public or the
public interest may justify an order intended to bring home to the
practitioner the seriousness of the practitioner's departure from
professional standards, and intended to deter the practitioner from
any further departure. A fine might well be imposed with this object
. . . An order might also be made in professional disciplinary
proceedings to emphasise to other members of the profession, or
to reassure the public, that a certain type of conduct is not
acceptable professional conduct. In the latter case the order is
made in part to protect the profession, by demonstrating that the
profession does not allow certain conduct. This, in the end, is also
in the public interest.”146
144
Transcript pp.759-765
New South Wales Bar Association v Evatt (1968) 117 CLR 17
146
(2001) 79 SASR 545
145
70
The Panel was also aware that the likelihood of repetition is central to the imposition of a
determination.147
Determinations
The Panel was of the unanimous view that, given the seriousness of the allegations
which it had found were made out, it was appropriate to reprimand Dr Traill under
section 45A(2)(c) of the Act.
The Panel also considered whether it was appropriate to suspend or cancel Dr Traill’s
registration.
The majority of the Panel decided that it was appropriate to cancel Dr Traill’s registration
for the following reasons:
•
There was no indication either during the hearing or after the Panel gave its
Findings that Dr Traill accepted he had acted unprofessionally to any extent.
While Dr Traill referred to learning from history, there was nothing to indicate that
he now regarded the conduct which led to the hearing and the Findings being
made as in any way inappropriate. There was no sign that he considered that
the views of his peers, particularly the expert witnesses, were worthy of
consideration and reflection; and
•
Dr Traill did indicate that he was not currently and unlikely in the future to engage
in the same form of treatments as dealt with in the Notice. However, this
appeared not to be because he accepted that the treatments were not
appropriate given that they are unproven and were subject to adverse comment
by this Panel and the NHMRC. Rather it seemed that he would not continue to
offer the treatments because he was semi-retired and, with the OncoCare Clinic
closed, there was no market for the treatments in Victoria. This did not address
the concerns of the majority that Dr Traill regarded it as acceptable to test his
theories as to treatments on patients outside the usual testing framework and
charge them. The majority considered that Dr Traill had given no indication that
he would not practice other forms of unconventional medicine if he believed that
they would have an effect.
These matters led to the majority having very serious concerns about whether Dr Traill
would change his approach to the practice of medicine if his registration was maintained
or after a period of suspension.
Despite the obvious impact cancellation would have on his capacity to earn an income,
the majority did not consider this overcame the need to protect the public from the
practices engaged in by Dr Traill and to bring home to him the seriousness of his
departure from professional standards.
The majority considered it of great importance that it emphasise to other members of the
profession and reassure the public, that the conduct which was the subject of the Notice
is not acceptable professional conduct and that it is the majority’s view that the
147
Health Care Complaints Commission v Litchfield (1997) 41 NSWLR 630 at 637
71
profession cannot allow that conduct. The majority considered that, in order to achieve
these aims, a lengthy period ought to elapse before Dr Traill could seek registration
again. The majority also believed that, when Dr Traill does re-apply, the Board should
consider having an assessment of his capacity carried out to assist it in reaching a
decision. Of course this latter comment is not binding on the Board and is a suggestion
only.
Dr De Zylva was of the opinion that Dr Traill’s practice might have been against
accepted norms of the medical profession in that few if any medical practitioners
promote the forms of therapy that Dr Traill practiced but in his defence there was no
definitive statement from the Australian Government or the NHMRC against the practice
until 29 September 2005.
Dr De Zylva was satisfied that Dr Traill firmly believed that he was offering some solace
to cancer patients who had been abandoned by conventional medical practice. There
was no evidence that his therapy adversely affected the final outcome apart from the
patient with small cell lung cancer (Ms SO) and that too is in dispute based on Professor
Richard Fox’s comments.
He felt that Dr Traill should be given the chance to formulate his future practice in the
light of the NHMRC document. Dr De Zylva felt that banning him from medical practice
totally would be too harsh a penalty – particularly if he no longer intends to practice in
this controversial field.
The formal Determinations of the Panel are:
The unanimous Determination of the Panel is that Dr Traill is reprimanded for his
conduct pursuant to section 45A(2)(c) of the Act.
Further the Panel (by majority, Dr De Zylva dissenting) has determined that Dr Traill’s
registration is to be cancelled pursuant to section 45A(2)(h) of the Act and that
cancellation is to come into effect at 5 pm on Wednesday, 26 October 2005. The
majority also determined pursuant to section 45A(2)(i) that Dr Traill is disqualified from
applying for registration under section 5 of the Act for a period of 3 years.
Dr G D Kerr
Chair
30 November 2005