AFFIDAVIT MADE IN THE PEOPLES    REPUBLIC OF CHINA

I,        DAVID GEORGE SPALL

of        102/5/111 Zingfu Road, Shanghai, Changning District, 200052, Peoples Republic of China,

Consultant Physician,   make oath and say that:-

BACKGROUND

1.1I hold a medical degree from the University of Colombo and have, in times past, been licensed to practise medicine in several different states of the United States of America. Immediately prior to my present appointment in a military hospital of the Peoples Liberation Army of the Peoples Republic of China, I had an appointment as Medical Superintendent and International Medical Director of a Klinik and Hospital in Germany.

My professional interest in hyperthermia (in every form) as an adjunctive treatment to chemotherapy and radiotherapy goes back more than thirty years. I have been privileged to attend clinical meetings and scientific meetings all over the world during these three decades. I am honoured to be a Vice-President of the International Society Clinical Hyperthermia.

1.2 From 1960 to 1980 I was employed in administration with the Medical Department within the Department of Health and Medical Services of the Government of Western Australia. For many years I was a member of the Radiation Advisory Council and a gazetted inspector under the Radioactive Substances Act. My responsibilities were primarily with the Diagnostic Radiological Services including delivery of radiological services to rural communities throughout Western Australia. I was heavily involved in the acquisition of high tech organ imaging which was emerging during the 1970's. Significantly, the acquisition of the first CT scanner in Australia which I had previously seen in use in London and presented to the world at the Radiological Society of North America in Chicago (November 1973). In addition, I became embroiled in the acquisition of the controversial Tronado UHF Hyperthermia System.


 

For eleven months (1973-1974) I was given sabbatical leave and, fully supported jointly by the State Government of Western Australia and the World Health Organisation, to participate at an international level in research and both giving and gleaning of information relating to improving the standard of radiological services, particularly in rural communities. In addition, I presented scientific papers at international medical meetings both in Europe and North America. My most significant contribution was in third world countries in the continent of Africa. I was privileged to lecture in universities and hospitals throughout Africa, Israel, Europe, Scandinavia and North America.

While I was in Europe, I was contacted by the then Minister for Health and Officers of the Premier's Department to investigate and report on the use of Hyperthermia (specifically the Tronado unit in Germany) where the Premier's wife had had extensive and successful treatment for breast cancer the previous year. I suggested that the appropriate person to do this was Dr. John Holt who was, at that time, Director of the Institute of Radiotherapy at Sir Charles Gairdner Hospital in Perth.

The UHF Tronado system was subsequently purchased with my full support albeit the subject of immense contention between the government of the day and the Royal Australasian College of Radiologists (Radiotherapy Branch). The saga of contention continues to this present day.

1.3 I was. therefore, an early witness to the trials and tribulations of the use of this
apparatus and the vilification of both Dr. Holt and Dr. Nelson. I also saw, first hand,
the clinical results of that early work.

1.4   I am the sole Director of Oncocare International Pty Ltd.   OncoCare is a service
provider in the area of UHF Microware Therapy, Hyperthermia and Thermotherapy.

1.5 This company owned and operated equipment to deliver various forms of
Hyperthermia by means of Infra-red (Whole Body Heckel Tent), Ultra High
Frequency Radiowave Therapy ("UHF") and Prostcare Thermotherapy in Melbourne,
Victoria from April 2000 to May 2003. For more than four years, immediately before
that, the facilities were operating in a private practice in Brisbane, Queensland.

1.6   The equipment was installed and maintained with a very well qualified Radio
Engineer from Melbourne. It was calibrated weekly and any deviation from the
designed output of energy was corrected immediately. This included the replacement
of thryotrons as they decayed and high tension Beldon cables.

1.7The company employed Nurse F during the relevant times to assist Dr
Traill in the delivery of various forms of treatment. I was responsible for training her
in the use of the several systems as described above. This was very much hands on
training in which both Dr. Malcolm Traill and Nurse F actively
participated.


 

1.8 I was involved wherever possible and at the request of Dr. Traill in the field planning and setting up of the initial sessions of treatments. There was, therefore, ample opportunity for patients to ask questions and for me to participate in the delivery of the various treatments.

1.9 It was common practice for Dr. Traill to invite me into his consultation room well after he had begun the consultation. This was always with the patient's permission. Indeed, I was always introduced as the Director and Chief Executive Officer of OncoCare International Pty Ltd. It was explained that I would participate in applying the treatment protocols under discussion.

In every instance, Dr. Traill would raise the importance of a clear understanding of the treatment options available (in particular, their limitations). He would, not infrequently leave it to me to go through the Consent and Indemnity Form, paragraph by paragraph and word by word with each patient.

No patient was ever treated at the clinic without a careful and thorough understanding of the Consent and Indemnity Form. There was no small print or anything hidden from the patient and I was particularly careful to admonish the patient regarding the fact that no guarantees of treatment response could be given. [Patients] SO and OT were no exception.

Not infrequently, presenting patients were already under the primary care of other specialist health care providers. It was made abundantly clear to each and every patient that you cannot have two cooks in the kitchen. Dr. Traill stressed the matter and I reinforced the issue wherever possible that the clinic could not be in conflict with any other treatment modality and, indeed, any other actively participating specialist must be aware of the patient seeking treatment at OncoCare.

Many prospective patients left the clinic disappointed when gently confronted with realistic expectations of the possible treatment outcome.

The following information is given without access to any medical or technical records pertaining to these former patients. I am, therefore, relying on memory which goes back now to September and December 2000 (more that five years ago). Unfortunately, the relevant facts are indelibly printed in my memory because of the ensuing trauma generated by the complainants.

In particular, the litany of blatant lies and deliberate misinformation has created a gross misunderstanding with the administrative authorities involved.


 

Ms SO

2.1 This unfortunate young woman, the mother of a then four year old child, who

presented with such a dismal prognosis obviously moved the heart and mind of all of the staff at the clinic with immense compassion. However, both her initial presentation as a patient and her subsequent behaviour are unforgettable.

With great respect to whomever this sworn statement may concern, be it known that this litigation and persecution of Dr. Malcolm Traill has been fabricated on one false premise, one blatant falsehood.

Ms SO presented to the clinic of her own free will and accord, initially without a referral, having rejected the chemotherapy from Dr. Tom Scarlett and, furthermore, adamantly refused the chemotherapy offered by Dr. Malcolm Traill. I personally witnessed her very verbose refusal of any kind of chemotherapy even though it was repeatedly stressed to her that she was putting her life on the line by so doing.

I vividly recall Dr. Traill looking at me during the consultation, utterly exasperated by her demands. It was made abundantly clear to her the difference between fever range Whole Body Hyperthermia which was invariably used conjointly with chemotherapy and UHF Microwave Therapy as used by Dr. John Holt in Perth, Western Australia. The latter treatment being used only with the injection of an agent that interrupted the biological cycle involving glutathione and the radio biology being totally different to that of fever range Whole Body Hyperthermia. The clinic in Melbourne had two major UHF systems built on this principle.

Unfortunately, Dr. GG of the Peter McCallum Clinic who initiated this complaint was totally misinformed of the fact that she rejected all forms of chemotherapy even when we remonstrated with her as to her folly. He, therefore, took this false statement as the truth and phoned Dr. Traill and abusively told him to pay her money back or he would report him to the Health Services Commissioner, the Medical Board and Ray Martin at Channel 9 Sixty Minutes program. When Dr. Traill phoned Dr. GG back he refused to discuss the matter and said that he had already reported him to the authorities.

Not only did Ms SO refuse all forms of chemotherapy at the initial consultation but in the vain hope that she may reconsider, Dr. Traill prescribed and ordered alternative chemotherapy agents and she refused to have them during the one only aborted Whole Body Hyperthermia session even though he had drawn up the syringes ready for injection. I personally witnessed the unused items on the sterile tray at the end of the brief failed Whole Body Hyperthermia session. Refreshment of my memory recalls my absence from the clinic when the initial session began and when I returned and put my head through the door of the treatment room I saw a very


 

exasperated Dr. Traill together with Nurse F with the patient who was obviously very distressed by the heat of the Hyperthermia. She was very flushed in the face and perspiring copiously. I clearly recall [Ms] SO saying, when Dr. Traill announced that she refused the chemotherapy, "No way, Jose".

Sometime, about twenty minutes later, Dr. Traill asked me to come to his consulting room to discuss other treatment options with Ms SO.

Once again, in my presence as a witness, Dr. Traill told Ms SO her only other option was to have UHF treatment and, although she would feel quite hot, the biological action was very different. He made it very clear that the preferred option was that which she had rejected. She was, therefore, offered UHF treatment concomitant with the injection of an agent to block the glutathione during the bio-mechanism cycle. For the record, Ms SO was given extra treatment without additional charge in the hope of either arresting further cell division or precipitating apoptosis.

2.2 There are, however, two salient and unforgettable issues concerning this woman which I perceived to be most unusual. In the first instance, her physical disposition and bouncy, breezy manner was most inconsistent with someone who had just had an untoward experience, who had reacted badly to three days of chemotherapy.

In the second instance, when she was given a copy of the Consent and Indemnity document, she looked at it briefly.   I then invited her to go through it carefully with me and I remember clearly her waving the document in her hand and declaring to both Dr. Traill and myself that the document was not worth the paper it was written on.   When Dr. Traill asked why, Ms SO retorted that it could be argued in court that the person signing the document was sick and under duress and did not understand the implications of the document. Dr. Traill replied with words to the effect, but Ms SO you are of a sound mind and understand what it says and means to which she replied, yes, of course I understand but the document is not worth anything. She was advised to take the document home with her to read it carefully but that no treatment would be given until she had signed the document. The plaintiff took the document with her, went back home and when she returned for treatment several days later, once again said she would sign the document but that it was not worth anything.

I was not a little concerned about this matter and I can only say that I had a very strong gut feeling that she may prove troublesome and possibly litigious.


 

Ms ST

3.1      [Ms] ST first came to the clinic on 22/12/2000. She flew over from Tasmania to
hear about the treatments that we performed. There was a referral letter from Dr
Russell Cooper. After Dr Traill initiated the consultation, he asked me in and the
treatments were discussed. She did not want either chemotherapy or DXRT at that
stage, saying that she was looking for some less damaging treatments to prevent or
slow recurrences. After a long discussion, she went back to Tasmania to consider
what she would do.

3.2      She returned on 22/1/2001. Dr Traill was not in the Clinic. I telephoned him and told
him of her arrival. He said that it would be appropriate to start treatments, because
they had been explained to her. She brought some ampoules of Eurixor and requested
that it be administered. I had never heard of this product, so I asked Dr Traill if he had
ordered it. He stated that he knew nothing about it, and asked me to read the packet
insert out to him. It was an extract from Viscum album (mistletoe). On hearing this,
Dr Traill felt that it would be safe to administer it as for Iscador (which I had
encountered before in clinics overseas), with low doses intradermally as set out in the
packet insert. I have never recommended mistletoe extracts; I do not know any details
of obtaining them and had never heard of Eurixor until she arrived with it.

3.3      I instructed Nurse F in the application of the superficial local Hyperthermia, with
particular care not to overheat the right breast, since there would be reduced sensation
in its skin due to the recent surgery. The protocols were those that I had seen and used
when overseas, and are summarized by van der Zee in her Review (Annals of
Oncology 2002 12:1173-1184).
(The clinic had the computerized equipment for intra-
tumoral thermometry, but this is not practical or reliable with air interface, superficial
local hyperthermia and, therefore, was not used). Dr. Traill asked me if I would
instruct Nurse F in the intradermal injections of Eurixor on either side of the scar.

3.4      Ms ST was a quiet lady and, apart from a faint that followed one of the Hyperthermia
sessions, for which Dr Traill was called, there was little untoward that happened. I do
recall her drawing attention to a sudden loss of heat from one of the antennae during a
treatment session. This, I investigated immediately and found that a high tension
cable had failed. This was replaced forthwith. At no stage did she complain about
the treatment, management or pricing. She was issued with a weekly itemized
account, which she paid promptly without comment.

3.5      I discovered the lost letter from Dr Linacre, and brought it to the attention of Dr
Traill. He noted that he had sent a copy of his letter to Dr Cooper to Dr Linacre
already, but a full response to Dr Linacre was needed. I gathered together the records
and, at the request of Dr. Traill, drafted up a letter for his response in preparation for
his next session at the clinic. To the best of my knowledge, the letter of response was
posted.


 

3.6       I was very surprised to learn that she had complained. This was particularly so when
Dr Traill and I went through the details of her complaint. I found it extraordinary and
was appalled to read the false claim that I was the person who prescribed the Eurixor
and the quite fanciful account of the lights on the antennae.

3.7       I will now comment upon the claims relevant to me or my experience of the events as
related by Ms ST in her Sworn Affidavit of 25/11/2004 (BoE45)

 

3.7.1                    (Para. 9.) The initial consultation (22/12/2000) was with Dr. Traill. He called me
into the consultation after its commencement. Her claim that the initial
consultation was with me is, therefore, false and misleading.

3.7.2        (Para. 10.) I did not advise Ms ST or any other person to obtain Eurixor ever. I
did not know of it at that time, did not know what it was, what it was for nor how
it could be obtained nor the protocol for its administration. This claim is also false
and misleading.

3.7.3                    (Para. 11.) Ms ST indicated that she did not want further Chemotherapy or Deep
X-ray Therapy at that stage. Dr. Traill indicated that there was a distinct
possibility of multiple drug resistance having developed after the previous
Chemotherapy courses. Neither Dr. Traill nor I said that she had "a multiple
chemical sensitivity or any words to that effect." This claim is also false and
misleading.

3.7.4        (Para. 14.) With regards to "I complained to him several times that the right hand
light on the local hyperthermia machine was not working." There was no light on
any of the units referred-to and her ability to feel and appreciate heat on the skin
over the mastectomy was assumed to be lessened. Because of the risk of burning,
the power level was reduced, so that heating would be slower and more
controlled. This was explained to her and, I believed, to her satisfaction. Her
claims about the matter are false and misleading.

3.7.5        (Para. 15.) The "light" does not become hot because it is an antennae for the UHF,
which is radio-wave energy radiated (not like a domestic radiator which radiated
intra-red heat). Her claim that the heat of the unit indicated the working state is
false and misleading.

3.7.6        (Para. 16a.) Apart from necessary maintenance, her claim that the "hyperthermia
machines regularly broke down" is false and misleading.

3.7.7        (Para. 16b.) "A technician was in attendance most days." is false and misleading.
The clinic radio engineer, Mr. Chuck Collins, attended the clinic quite often as an
essential part of maintaining the apparatus.


 

3.7.8    Para. 18.) The original brochure ("ST-5") listed treatment options that were

available. The example presented here by Ms ST lacks the odd numbered pages and, accordingly, is very incomplete. It does not contain pricing. She has not produced any written quote. The expected costing was presented to her clearly and without ambiguity. On this basis she elected to proceed. She was given an itemised bill at the end of each week, which she paid without question or comment. She received the treatment she requested and the bills were in accord. Her account is false and misleading.

Sworn at    Shanghai, Peoples Republic of China

this   29th day of    March                    2006

                           

 

                    Signature of deponent making this affidavit

 


                   Signature of authorized witness

                 Kay Dunn

                 Consul

_________________________________________________________________________________

 

OncoCare Cancer and Prostcare

Clinic

31 Station Street Fairfield Victoria 3078

Telephone: (03) 9482 1022    Fax: (03) 9482 1099 E-mail: happydoc@bigpond.com.

MEMORANDUM FOR THE RECORD

DATE:3 July 2003

RE:     SPECTRAL PATTERNS OBSERVATIONS ON CRO DURING TRONADO (ERBE) UHF TREATMENT INSTITUTE OF RADIOTHERAPY SCGH PERTH WA

From April through until December 1973, I was privileged to travel extensively throughout the world visiting hospitals and clinics under the auspices of the Medical Department, Department of Health, W A State Government.

Whilst in Europe I was asked to look at a Tronado Hyperthermia System on behalf of the Minister for Health. This I did and considering it to be a useful adjunctive treatment for cancer I recommended that Dr. John Holt, the then Director of the IRT, to inspect the facility.

The apparatus was acquired in 1974 amidst much controversy from within the university teaching hospitals, both RPH and SCGH and the WA branch of the Royal Australasian College of Radiologists (radiotherapy group).

I was in frequent attendance at the IRT observing its initial installation and a number of treatments over the ensuing months. It was, indeed, a privilege to be a witness to the first group of patients being treated with hyperthermia.

An interesting phenomena was observed very early in the initial phases of the project which Dr. Holt followed up with physicists and engineers from the Institute.

The phenomena appeared on the spectrum analyser. I refer to the appearance of irregular and inconsistent random patterns when the antennae were in close proximity to tumours. I well remember the day when the installing engineer from Erbe agreed to stand in the field of energy as an experiment because he could not believe that these glitches were related to the suggestion of a possible fluorescence from tumour.

OncoCare Clinic is a trading name for OncoCare International Pty Ltd

ACN 091 983 032 ABN 17091 953032


 

To the immense surprise to the assembled group of observers a small glitch appeared on the spectrum analyser CRO as the antennae moved slowly and hovered over his chest. He maintained he was in perfect health and it seemed that the suggestion of the glitches being related to tumour fluorescence was incorrect. The antennae was repeatedly moved up and down his thorax with the same glitch on the shoulder of the standard wave pattern. He agreed to a chest x-ray and a lesion was found in his chest.

I saw this experiment repeated a number of times over the ensuing months by a large variety of tumours with the same effect. I believe that Dr. Holt's hypothesis is correct and that these wave patterns are related to the fluorescence of tumours to non-ionising radiation in the area of 425 and 440 MHz.

         

Dr David G. Spall

OncoCare Clinic is a trading name for OncoCare International Pty Ltd

ACN 091 983 032 ABN 170 919 530 32