Friday, August 19, 2011

Owen McShane: Maori at the Crossroads

A group of Maori organizations and Iwi leaders are sending some clear signals to other Maori, and to Government in particular, that they are standing at a crossroads.

One road will take Maori into a future in which they participate in the modern world, and contribute to economic growth and development, driven by technology development and employing people on high wages. They may also benefit from growing dividend streams as a result of significant investments in state owned enterprises.

The other road locks them into the world view of tribalism, and in particular enforces the religious beliefs of pre-European times, such as mauri, and taniwha and which regards science as the enemy – being the “latest force of colonization”.

This is the time for Government to clearly signpost the road both Maori and Pakeha should want Maori to chose, for their own benefit and for the general health of society. Namely, Government should make clear its preference for the policies and actions of the forward-looking modernists, over the policies and actions of the backward-looking reactionaries.

The story that follows may seem only loosely connected to these big issues but it retraces a journey that leads to this conclusion.

The Influence of the Reactionaries on Clinical Trials and related Registration Processes.

One example of the way the Tribal World View, promoted so vigorously by a small number of Maori academics and conservative tribal leaders, is holding back our technological development is the impact of the Treaty of Waitangi clause on the registration of new medical and biological technologies in New Zealand.

Recently, Fisher and Paykel Healthcare announced that the company may have to move the clinical trials of some of its medical products offshore because the process here has become more and more complex and is now simply “too slow” compared to similar processes overseas.

Read the story and watch the TVNZ news video here:

The interviewee is one of New Zealand’s true multinational enterprises with offices in nineteen countries.
The written story explains that Michael Daniell, the CEO of Fisher and Paykel Healthcare, is seriously concerned about the problems now associated with conducting clinical trials in New Zealand.

However, he also announced that the future now looks brighter, and he has already noticed recent improvements. Government recently launched a review of the registration processes after studies showed New Zealand’s annual earnings from clinical trials had more than halved over 10 years from roughly $100 million to $45 million.

Mr Daniell has received a copy of the report and is very pleased with the findings and recommendations. He is hoping that further rapid responses from the Government will enable Fisher and Paykel Healthcare to carry out more of its clinical trials in New Zealand and help build the “clinical trial” business within New Zealand. For reasons of its own TV One edited out all Mr Daniell’s positive comments, and his hopes for a better future, and chose to focus on the “bad news” instead.

So this Digest is an opportunity to set the record straight and to encourage Government to implement the necessary reforms as soon as possible. There is more at stake than may first appear.

My Personal Interest in the Field.

During my time at the Development Finance Corporation (DFC) I was involved with funding some of Fisher and Paykel Healthcare’s early development projects. Last December it was comforting to look over the side of my bed in the Critical Care Unit of Auckland Hospital and see that I was being helped to stay alive by the F and P respiratory humidifier. What goes around comes around.

Much of my work in the DFC focused on bio-technology and medical projects. My early work with the Auckland Cancer Society Research Laboratories soon made me aware of the fact that many multi-national pharmaceutical companies were carrying out their clinical trials in New Zealand because of the many advantages we offered at that time. I also became acutely aware of the benefits to our researchers and innovative companies that flowed from the network of contacts that came with these contracts.

I personally benefited, being the only person from the Southern Hemisphere invited to make a presentation at Bio-Tech ’82, the world’s international bio-technology conference at Wembley Stadium, London. My paper was titled Commercialising an Eco-system, the eco-system being the thermal pools of Rotorua which provided a comfortable home for a diverse range of extremely thermophilic organisms. This invitation was largely because I had become reasonably well known to the key networkers.

Consequently, I was dismayed to see the item on TV One News. This looked like yet another sad commentary on our seeming inability to maintain high-added-value activities in New Zealand, especially at a time (which should be all the time) when we are trying to diversify our business activity into sectors that pay high wages, unlike tourism and farming which don’t.

However, it was not a total surprise because I was aware that the rot had been setting in for some time.

Scientists expect to work with other Scientists and to deal with Scientific Matters.

In those early days clinical trials were conducted and managed by scientists on behalf of other scientists. Then in 1996 the standard Treaty of Waitangi Clause was built into ERMA and the Hazardous Substances and New Organisms (HSNO) and has slowed down the registration processes from day one, just as so many of us predicted. The HSNO Act requires: “All persons exercising functions and powers under the Act to take into account the relationship of Maori and their culture and traditions with their ancestral lands, water, sites, wahi tapu, valued flora and fauna, and other taonga (Section 6) and to take into account the principles of the Treaty of Waitangi (Te Tiriti o Waitangi) (Section 8).

The 1999 ERMA publication, Working with Maori under the HNZO Act 1996 identifies issues of relevance to Maori including the following list of cultural outcomes:

Potential issues of significance in relation to cultural outcomes

The following list of cultural outcomes has been identified as important to Māori. If your application is likely to affect these desired outcomes then the Authority will need information about these effects.
·      the sanctity of Māori cultural health and well-being·      the recognition of Māori cultural, spiritual, ethical, or socio-economic values·      the protection of the mauri (spiritual integrity or life-force) of people·      the preservation and maintenance of traditional Māori knowledge by Māori·      the protection of the mauri of Māori culture, language and knowledge·      the maintenance, expression and control by Māori of their traditional practices eg kaitiakitanga,  tapu, rāhui·      the protection of the mauri of valued flora and fauna·      the protection of the mauri of land·      the protection of the mauri of waterways (inland and offshore)·      the protection of the mauri of air and other taonga.

Imagine you are a scientist wanting to run clinical trials for a new pharmaceutical or vaccine developed in your headquarters in Switzerland. You have heard from your colleagues that New Zealand is an excellent location for such trials. So you open up this report and read that list above.

It is a daunting list for a scientist to cope with, and the US or Germany or Switzerland itself look more cost-effective and efficient by comparison. How can you possibly report on the impact of your new pharmaceutical on “the spiritual integrity or life force of people” without sacrificing your own scientific integrity?

The Treaty and the Ethics Committees.

The relevant Treaty clause governing the operations of the seven Regional Ethics Committees (which deal specifically with Clinical Trials and related processes) reads:

There is a need to ensure that issues of relevance to Maori, the indigenous people of New Zealand, are addressed. Ethics Committees have an obligation consistent with section 4 of the “New Zealand Public Health and Disability Act 2000” and “He Korowai Oranga”, to ensure research recognises and respects the principles of the Treaty of Waitangi. Ethics Committees will require evidence of appropriate consultation with the relevant groups.

Clinical trial sites and Clinical Research Organisations in New Zealand have access to the relevant groups in order to facilitate the consultation process. There is no cost associated with this process.

There is no cost associated with the process of consulting with Iwi provided time has no value. The HSNO organization offers a helpful manual that lists the 50 odd Iwi that may need to be consulted regarding a new substance or plant intended to be used throughout New Zealand.

Unfortunately, for those involved in the “race to the market,” time has almost infinite value, and indeed, high-tech innovation is just as subject to the costs of DURT (Delays, Uncertainties, Regulation and Taxes) as the construction sector.

The Sorry Story of a Clinical Trial using Honey as an Antiseptic.

A case study of a minor clinical trial, written up by Shaun Holt in the NZ Herald in 2009, is titled “Our Ethics System is now so Unwieldy, it’s Unethical”. He writes:

Last year I submitted an application for a simple study to see if honey could help treat a common skin infection in children that is otherwise very difficult to treat. Only 15 children were required for the study, and all the caregivers had to do was to apply the honey, cover with a dressing and see if it seemed to help.

In order to apply to the ethics committee, I had to consult a Maori health provider to make sure there were no cultural issues if any Maori children took part and see a Justice of the Peace to sign a statutory declaration.

The application itself needed around 9000 words to complete and over 350 pages had to be submitted. For a study which could not be any simpler and had almost no chance of causing any harm, the application process took longer than doing the study would have.

The study was rejected by the committee and around 40 points were raised, most of which were either wrong or not relevant to the ethics of the study. For example, I was told to consult at least two more Maori health providers and to have systems in place for interpreters, even though the study was to be undertaken by a few GPs who would ask their own patients with this condition if they wanted to take part.

This example demonstrates how the ethics review system is extremely onerous for researchers and not capable of quickly approving simple ethical studies. Rather than the international standard of five committee members of whom one is a lay person, New Zealand requirements are for 12 members of whom at least half are lay people, and a lay person chairs the committee.

Medical researchers are hugely frustrated by the quality of the ethical reviews of their proposals, the work required for an application and the time taken for the responses and approvals. One of our leading orthopaedic surgeons has said the greatest impediment to medical research here is the growth of the ethics committee process.

The global clinical trials industry is worth over US$60 billion and is growing rapidly, yet we undertake only around US$10 million here.

Also, clinical trials give participants free access to the latest medications and reduce the burden on the health system.

The New Zealand medical research ethics review system wastes researchers’ time and energy and stops good research that can be of huge benefit to our health and economy. This surely is unethical.
·      Shaun Holt is a doctor, researcher and author.

Shaun Holt has also written extensively about the growth potential of the clinical trial industry in New Zealand if it was freed from these “cultural” shackles.

See, for example, his essay, Drug trials could be big business in NZ, in the NZ Herald of June 18, 2008.
In 2008 he was committed to building the business here, and formed a company to promote the relevant enterprises and activities. A year later his first hand experience with the honey trial indicated that excessive red tape had seriously compromised the prospects for growth.

When I was working with the Auckland Cancer Labs licensing their anti-cancer drugs overseas, companies were lining up to do their clinical trials in New Zealand because we provided such a good environment – and in particular we had several cohorts of different ethnic groups, all within a single region.

Researched Medicines Industry Association chief executive, Ken Shirley, said New Zealand enjoyed a vibrant clinical trials industry until 1998.

“We had a $100 million investment in pharmaceutical (research and development) mostly in clinical trials. Today that's less than $20 million so we're a fifth of what we were 10 years ago, and still shrinking.”

When a researcher cannot even test honey because of the time required to consult with Iwi we have really shot ourselves in the foot.

The Fisher and Paykel announcement was not driven mainly by frustrations with Iwi consultation because their devices do not get caught up in the HSNO and ERMA processes. However, there is a saying that the convoy is only as fast as its slowest ship. Similarly a bureaucratic process is only as fast as its slowest sector, because that sector soon sets the timeframes and the expectations for performance.

The Reactionary Hostility to Science/Research as a “Weapon of Colonisation.”

Long delays are not the only issue. We have already argued that international scientists expect to deal with scientific issues and are scared off by any regulations that require them to address the possible impact of their drugs or vaccines on the mauri (the life force) given that modern science does not admit to the existence of a “life force” and certainly cannot measure any impacts on it. Some Maori also object to any interference or impact on genealogical purity which means they instinctively oppose any and all genetic modification, even though all antibiotics are produced from modified organisms and, in particular, modified bacteria now produce human insulin for the treatment of diabetes.

But probably the biggest “turn off” is likely to be the open hostility to science expressed by the Academic Reactionary Maori leadership. For example a power point panel (number 13) from a 2006 presentation on the Role of Maori Participants in Ethics Committees lists as “Ethical Issues for Maori”:

- language as the perfect tool of conquest and acquisition
- science/research as yet another weapon of colonisation
- colonisation of the land, colonisation of our minds, colonisation of our bodies
- globalisation of culture and identity

Which hardly encourages consultation between international scientists and Iwi.

Furthermore, if this represents the Maori “world view”, as claimed by the academics and tribal elite behind these messages, what is the impact on young Maori and their future participation in an economy increasingly driven by science and technology?

How can any Maori leaders claim to care about future generations if their actions and ideas condemn those future generations to low wage jobs or unemployment.

Balancing Freedom of Religious Belief with the Public Interest.

Of course any individual or group is free to believe what they like, and Maori individuals and groups are free to use or reject western medicine and science. On the other hand religious freedom works both ways and Maori have no right to impose their beliefs on others.

Everyone is familiar with the problems of achieving a sensible balance between freedom of individuals and the impact of those beliefs on others– or even themselves and their children.  The Jehovah’s Witness rejection of blood transfusion is a well-known example.

In these times we struggle to deal with the conflict between those who believe abortion is “a woman’s right to chose” and those who believe abortion is the murder of the unborn child.

We also have to deal with the growing tide of opposition to vaccination – which makes management of outbreaks of disease more difficult to control.

My personal experience with the Ethics Committee process has been that the Maori who actually sat on the Ethics Committee dealing with Professor Bob Elliot’s xenotransplant treatment of insulin dependent diabetics were strongly of the view that Maori are individuals, with no common “world view” and that Maori should be free to make decisions of their own free will and not claim the power to dictate such decisions to others.

The animal rights activitists were much more strident and extreme in their views, holding that no pig should die to provide the pancreatic cells that might save hundreds of human lives.


Anonymous said...
Reply To This Comment

Excellent article - let it be a wake up call! When is the Government and public of NZ going to stand up to Maori who are trying to drag everyone backwards?
If Maori genuinely want to reject all the benefits of modern life and technology then it is time that they turned off their TVs, stopped driving cars, stopped using the NZ health system - be bold enough to reject all Colonial medicine and health care - reject everything European and withdraw to a pre-European lifestyle - no financial support or interference from the colonial government.
Its time the Government and the NZ public called the bluff of Maori. If they want to stand alone it is time that they did so and become fully and financially independent of the rest of NZ.

dondiego said...
Reply To This Comment

The (part)maori are anti-technology. Which is surprising, in that after television the Mitsubishi Pajero is their greatest invention.
However- the Devil is in the Detail.
In the split-second Govt/N.Z stop calling them "indigenous" and give the true title "Successfully Genocidal Early Settlers" the second paragraph of your sub-heading The Treaty & Ethics Committees ceases to be relevant.
Along with nonsensical U.N rubbish/participation.
New Zealand could, in theory, be saved from itself...

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