EDITED PRESENTATION
BY DENIS STRANGMAN (CHAIR IBTA) TO AGOG (AUSTRALIAN GENOMICS AND CLINICAL OUTCOMES OF HIGH
GRADE GLIOMA) STRATEGIC PLANNING MEETING
The International Brain Tumour Alliance (IBTA), which I
Chair, was established at the combined meeting of the US-based Society for
Neuro Oncology, the World Federation of Neuro-Oncology, and the European
Association for Neuro Oncology, held in
About 50 people – including patients, clinicians, researchers, scientists, caregivers, and brain tumour charity officials from 11 different countries – came together to establish the IBTA.
In our relatively short existence we have sought: (a) to encourage the establishment of brain tumour patient and caregiver support groups in countries where such groups don't yet exist, (b) to advocate for equal access to promising new therapies, and (c) to facilitate global communication between brain tumour patient and caregiver support groups, brain tumour-relevant organisations, and researchers and medical personnel involved in the field of brain tumours.
My involvement stems from the fact that I am a “cancer consumer” which, in the definition of Cancer Voices Australia, is “someone who has been affected by cancer”.
I have been “affected” in so far as my wife was diagnosed with a glioblastoma multiforme brain tumour in June 2000 and died just twelve months later.
Not many brain tumour
consumers
It is extremely difficult to identify and attract “consumers” from within the brain tumour area. I have been trying to do that for the past six years, with varying degrees of success. There is no denying that the “ideal consumer” is someone who is currently undergoing treatment or is in remission but “remission” is not a word that you hear often in the world of primary, malignant brain tumours. Long-term survivors are often dismissed as having been “misdiagnosed”.
I have seen it all at first hand: the seizures, comas, DVTs, resection, radiation therapy, chemotherapy, dexamethasone and cushingoid symptoms, Manitol rescue therapy, and so on and so forth. The proverbial “roller coaster ride”.
Is it little wonder that many former carers, when approached to become consumer advocates for brain tumour patients politely shy away. Many want to close the door on what has been the worst possible experience of their life, something which not many of their friends and relatives fully understood.
NICE (
I want to refer briefly to experiences which have shaped my attitude to brain tumour research and the regulatory approval of new therapies.
Soon after the formation of the IBTA UK brain tumour groups were plunged into the process of obtaining regulatory approval via the UK NICE for Gliadel wafers and the concomitant therapy for newly diagnosed patients, which had already been approved in the USA, Australia, Canada and most developed European countries but not then in the UK.
The IBTA was involved in a consortium of the principal brain tumour charities that undertook a campaign around these applications.
That deep involvement in the NICE consultation and evaluation process brought me face to face with the unpleasant side of a regulatory body seeking to minimise patient access to new therapies, way beyond what was being practised elsewhere and, indeed, beyond the findings of the Stupp RCT.
It was similar in
Genetic markers
Brain tumour patients and their caregivers are often well aware of the dismal prognosis for their disease and this drives some of them to keep abreast of the latest clinical trial developments and emerging new therapies. There are very well developed international email discussion groups which facilitate the exchange of this information.
This group of patients and caregivers, like many of you, have hailed the emergence of genetic markers for the fashioning of personally-targeted therapies.
I have often warned, however, that this same information could be used by regulatory authorities to implement a poorly-founded method of discrimination against patients and so, before access limiting methods based on genetic markers are incorporated in any public subsidisation policy for a brain tumour therapy, they must be rigorously examined and validated on an internationally consistent basis. Two European leaders in the brain tumour field, Martin van den Bent and Johan Kros, have called for the development of standards for molecular assays in an article in the Journal of Neuropathology and Experimental Neurology last December.
Furthermore, patients will be better protected by the development of standardised assays which presuppose that there is the proper collection and storage of tissue. As is now being stated more frequently: “Tissue is the issue”.
Clinical trials
If I could turn for a moment to the question of clinical trials. As one of its primary objectives this group believes that its data will better inform the design of clinical trials for brain tumours and I acknowledge that tomorrow’s meeting of COGNO will most likely examine trials in more detail.
Some cancer consumer advocates have noted the discussion taking place about the appropriate use of end points in brain tumour clinical trials.
It seems to me, as a layperson, that, granted the paucity of new therapies and the dismal prognosis for our disease that the measurement of progression free survival is now a valid, and in some cases the preferred, end point for many clinical trials.
The true nature of
brain tumours
Criticism of the recent FDA decision vis a vis Avastin and breast cancer, for following the PFS path, has made me even more determined that we in the IBTA, and all of you who are part of this new initiative, should campaign strongly for a recognition of the true nature of brain tumours and the unique challenges they pose in the cancer context.
I heard Professor Ian Frazer (the developer of the cervical cancer vaccine) say on ABC radio last week how 60% of cancers are now curable. No one who knows anything about brain tumours says that about our disease and I am sure he would be aware that brain tumours are not among that 60%.
In a forthcoming brochure to promote the IBTA’s awareness-raising projects for 2008 we will be using this summary on the front cover:
Brain tumours are one of the most
difficult of all cancers:
- affect people randomly
- the cause of most
primary brain tumours is unknown
- no realistic universal
screening
- no known preventative
option by healthy living, diet or exercise
This mantra is entirely self-evident
to anyone who knows anything about brain tumours but we are up against a fairly
strong emphasis these days on early detection, screening and prevention, not
just in cancer control but in health generally.
Just last week the Australian Health
Ministers in their Joint Communique stated:
“Today’s meeting identified the
areas for immediate focus by the Health Ministers” and the fourth dot point was
… “Focusing the system on prevention”.
It is possible that in 20 or 30
years time, as a result of the data collected by the AGOG project, new insights
will be discovered about causes and the possibility for early detection and
prevention but until that time comes the focus in brain tumours must be on
progressing research, current treatments, and improved patterns of care,
including better patient and caregiver support.
Identifying possible causes is an
uphill task. The Americans have just spent $12 million trying to get to the
bottom of a supposed link between the work environment and procedures of the
Pratt and Whitney jet engine plant and a brain tumour cluster involving former
employees. According to a recent issue of the New Scientist magazine no causal
link is likely to be announced in the findings due later this year.
I am afraid that knowledge about
primary causes and their early detection is just not relevant to brain tumours
at the present time, in a way similar to how lung cancer might be related to
smoking or mesotheliomia to asbestos.
Dr Patrick Kelly, a neurosurgeon in
None of the admirable objectives of screening, early
detection and prevention, and advocacy of a healthy lifestyle – which now seem
to dominate cancer control policy in the developed countries - should be
undertaken at the expense of a continuing emphasis on research and support,
particularly for the more intractable cancers which are often the less common cancers,
including pancreatic cancer and brain tumours.
We should acknowledge that the
Cancer Council NSW, by its support for this very relevant brain tumour project,
pursues a balanced approach.
Statistical data
Could I also ask the project leaders
to keep at the back of their mind the possible implications of their proposed
collection of statistical data and the exemption provisions of the Disability Discrimination Act which
allow companies to discriminate in regard to annuities, life insurance and
superannuation. This discrimination can be based on available actuarial or
statistical data. Data you generate and publish could also be used as the basis
for decision-making by health insurance companies, although we in
International links
As well as our links with US
institutions,
We should also make efforts to
entice the Europeans to visit
As some of you are aware the IBTA
has been seeking to place a spotlight on the abysmal standard of care received
by brain tumour patients in the less developed countries. To that end we
commissioned research last year by the Central Brain Tumor Registry of the
United States (CBTRUS) about the incidence of brain tumours in these countries
and we are currently seeking support for a small official survey of the
patterns of care in a representative sample of such countries.
Nor should we ignore our friends in
Conclusion
I cannot conclude without a plug for
the IBTA’s current awareness raising projects – the Walk Around the World for
Brain Tumours and the 2nd International Brain Tumour Awareness Week
to be held during 26 October – 1 November. We have attracted support from more
than 100 brain tumour and cancer-related patient groups, professional
organisations and research institutions around the world and would be delighted
to include your institutions should they be willing.
Finally, may I thank the initiators
of this project for involving a consumer advocate in the process and its future
oversight. Some researchers and clinicians – not anyone present here, I hasten
to add - tend to believe that health consumer advocates more appropriately
belong in Taronga Park Zoo, the tram to which I used to travel on just outside
this Hospital as a child some 55 years ago!
I am very pleased to be a part of
this welcoming environment for what is truly a pioneering endeavour.