Hi Hilary

I have already sent the letter to the Cancer Society but will add in your names if there is a chance later.

Best wishes

Denis Strangman
=============

At 04:38 PM 12/07/2008, Hilary OBrien wrote:

Hi Denis,
 
Can you please add Darren Anderson and I's name to this.Its unbelievable there are no clinical trials in Nz.
I remember asking Darrens oncologist if there were any a few months ago.Thats the reason we
decided to go to the USA and Darren is now under the care of Duke with Dr.Henry Friedman.
 
Regards
 
Hilary O'Brien-Anderson

----- Original Message ----
From: Denis Strangman <string@...>
To: nzbraintumour@yahoogroups.com
Sent: Saturday, 5 July, 2008 7:28:34 PM
Subject: [nzbraintumour] Clinical trials in NZ.

Hi

The International Brain Tumour Alliance (IBTA) has always worked closely with brain tumour patients and their caregivers in New Zealand, supporting local people when the question of temozolomide approval was under public discussion back in 2004-2005.

We have a continuing interest in promoting access to brain tumour clinical trials, believing that they can assist patients. We have picked up some information about the impasse reached between the NZ government and the major pharmaceutical companies and the companies' decisions not to include NZ in forthcoming clinical trials. This impasse needs to be broken and one way might be for an "honest broker" to intervene. We believe the Cancer Society NZ could undertake the role of a neutral third party and for that reason I have drafted the following letter to be sent to the CS NZ from the IBTA.

If anyone wishes to have their name and address associated with the letter please email me privately at: chair@theibta. org

Best wishes


Denis Strangman
Chair IBTA
www.theibta. org
============ ==

DRAFT

Mr Dalton Kelly
Chief Executive
Cancer Society of New Zealand
PO Box 12700, Wellington 6144
 

Dear Mr Kelly
 

We are writing to express our concern at the lack of pharmaceutical company-sponsored oncology clinical trials in New Zealand.
 
Over the past decade there has been a steady decline in industry funded pharmaceutical research and development in New Zealand, particularly in the area of clinical trials.
 
This situation places New Zealand patients at a serious disadvantage to their counterparts in Australia, Europe, North America and many other countries where pharmaceutical company-sponsored clinical trials are more prevalent.
 
The International Brain Tumour Alliance (IBTA) is an advocacy and awareness raising organization and as such it seeks to represent the interests of brain tumour patients and their families worldwide. We are monitoring several promising brain tumour treatments which are in late stage clinical development.
 
While not yet commercially available, these treatments are accessible to patients through clinical trials in other countries. Without access to these clinical trials New Zealand brain tumour patients are missing out on novel cancer therapies, many of  which are improving quality of life, delaying time to progression, or prolonging survival.
 
The problem is exemplified by the fact that currently there is not one clinical trial, either industry or publicly funded, available to adult brain tumour patients in New Zealand.
 
The IBTA would like to encourage the Cancer Society to take steps to rectify this current impasse, and in doing so improve access to the latest treatments for all New Zealand cancer patients.
 
Background
 
There has been much recent publicity concerning the growing disparity in the access to pharmaceuticals by New Zealanders compared with Australians, in particular access to the high cost, new generation of cancer drugs. 
 
Clinical trials are the mainstay of new drug development and the majority of these are initiated by pharmaceutical companies which collectively invest up to US$60 billion per annum in research and development worldwide.
 
However, what seems to be emerging is that most of the major multinational pharmaceutical companies are refusing to sponsor or support clinical trials in New Zealand in preference to neighbouring Australia or developing countries such as India and China.  
 
This is to the serious detriment of New Zealand cancer patients who are being denied access to potentially ground breaking new medicines.
 
Importance of Clinical Trials in Oncology
 
The importance of clinical trials cannot be understated, particularly in areas such as oncology where clinicians and their patients are often faced with limited treatment options, and in the case of incurable cancers, standard treatments which are at best palliative.
 
Rapid advances in the understanding of cancers at the molecular and genetic levels are fuelling the development of new, targeted treatments which are providing fresh hope to cancer patients around the world.
 
In particular, some of the less common cancers, which for many years have not received any meaningful advances in new treatments, are now attracting the attention of researchers.
 
One such cancer is malignant glioma, a type of brain tumour, the most common and the most deadly of which is glioblastoma multiforme (GBM).
 
The incidence of malignant brain tumours is not as high as the big four cancers of lung, breast, prostate or colorectal.  But because they frequently strike at a young age and are invariably fatal, malignant brain tumours are rated as one of the most severe cancers in terms of person years of life lost (PYLL). According to research conducted by the Cancer Council NSW they also result in some of the highest costs incurred by families and the health system.
 
Brain tumours are also regarded as one of the most intractable cancers as they attack the core essence of a person’s being and can result not just in physical deficits but intellectual, emotional, behavioural and personality changes.
 
With current standard treatment, the median survival for GBM patients is a little over one year. However in recent years gliomas have attracted increased interest from the cancer research community and many of the major pharmaceutical companies have products targeted towards GBM in their development pipeline.
 
Consequently there are over a dozen novel treatments for GBM which are in current late stage clinical development, including the following agents.
 
Bevacizumab, trade name Avastin (Roche), is a humanized monoclonal antibody which is already approved by the FDA for some forms of colon, lung and breast cancer and is about to enter phase 3 trials overseas for newly diagnosed GBM.
 
Cilengitide (Merck) is an integrin inhibitor which has exhibited very promising results in phase 2 trials for relapsed GBM and is about to enter phase 3 trials for newly diagnosed GBM in Europe, the USA and possibly Australia.
 
Cediranib, trade name Recentin (AstraZeneca) , is a small molecule tyrosine kinase inhibitor which has also performed well in phase 2 trials and is about to enter phase 3 trials in Europe, the USA and Australia.
 
CDX-110, developed by Avant Immunotherapeutics and licensed to Pfizer for worldwide marketing rights, is a therapeutic vaccine which in phase 2 trials doubled the median overall survival for newly diagnosed GBM. A phase 3 trial is being planned for later in 2008.
 
All four of the above agents have shown promising efficacy compared with standard treatments in treating malignant gliomas in early to mid stage clinical trials and are about to start final stage (phase 3) clinical trials.
 
All four drugs are being developed by multinational pharmaceutical companies with a marketing presence in New Zealand: Roche, Merck, AstraZeneca and Pfizer. However little or no research is being conducted by these companies in New Zealand and they currently have no plans to offer any of their phase 3 trials to New Zealand patients.
 
However, at least two of the above phase 3, pharma-sponsored clinical trials will have participating centres in Australia. In addition, pharma-supported research (where the pharmaceutical company supplies the trial drug) is allowing some Australian hospitals to conduct their own studies with these new agents.
 
Without any pharma-sponsored or pharma-supported clinical trials, New Zealand brain tumour patients have little hope of gaining access to these important new drugs.
 
In summary, many Australian brain tumour patients, and those in Europe, the US and many other countries, are obtaining access to these state-of-the- art, new therapies during their late stage development, while New Zealand patients are missing out altogether.
 
Economic Impact of Clinical Trials
 
It is not only New Zealand patients and their doctors who are missing out. The New Zealand health research community and the economy as a whole are, we feel, also being deprived.
 
New Zealand prides itself on being a nation of innovators and forward thinkers. A prominent feature of our economic strategy in recent years has been the drive towards becoming a “Knowledge Economy”, where new technologies, innovation and creativity are embraced.
 
Biotechnology and bio-medical research fit well within the framework of the Knowledge Economy, yet the paucity of clinical trials conducted in New Zealand makes a mockery of this economic vision.
 
A robust and profitable bio-medical research sector provides advantages on multiple economic fronts, including: commercial success; skills and infrastructure development; and substantial cost savings to the health sector.
 
Many countries have long identified the benefits of a healthy medical research sector and are being pro-active in procuring clinical trials for their citizens. In a move to promote patient equity, the UK government is in the process of introducing a formal right for patients to be informed of clinical trials from which they might benefit.
 
 
The International Brain Tumour Alliance (IBTA)
 
The IBTA supports responsible initiatives, private or public, which aim to increase the number of brain tumour clinical trials in New Zealand.
 
We believe there is an opportunity for the Cancer Society to campaign for the extension of international, pharmaceutical industry-sponsored clinical trials to New Zealand centres, for the betterment of the New Zealand cancer patient community.
 
The first step will require efforts to break the impasse with the major international pharmaceutical companies and we believe that the Cancer Society is well placed to act as an “honest broker” in this matter between the Government and the industry.
 
We look forward to your response and suggestions for progressing this matter further. I anticipate that I and my colleague, Kathy Oliver (UK), will likely meet you during our attendance at the World Cancer Congress where the IBTA will have a panel display.
 
With best wishes
 

 
Yours sincerely
 

Denis Strangman
Chair
 
Note: I have been assisted in a consideration of this subject and the drafting of this letter by New Zealand resident Mr Chris Tse, who works closely with the IBTA in a voluntary capacity. Chris’s wife Lynda has a glioblastoma brain tumour. Our approach to you and the Cancer Society New Zealand is also supported by the following residents : ��������………�
 




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