Afternoon all,below is an e-mail sent to the Health Minister by...

Afternoon all,

below is an e-mail sent to the Health Minister by Al Gordon (President of The Islet Foundation) which is a good read...

Perhaps Cunliffe's delay has something to do with the looming elections in NZ and a secret political agenda is the only credible explanation for the ongoing delay...

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Dear Minister Cunliffe,

I have written to you on several previous occasions regarding your failure to finalize approval of the pending clinical trial by Living Cell Technologies (LCT). This trial will continue the testing of encapsulated porcine islets for the normalization of blood glucose control in people suffering from juvenile (autoimmune) diabetes, trials that have already been approved by New Zealand's safety and ethics councils.

As you are aware, the normalization of blood glucose control will remove the cause of the horrific complications of autoimmune diabetes, including blindness, amputation, kidney failure, crippling nerve damage, heart disease, and early death, fates suffered by children and adults alike. And for all New Zealanders, there is the massive financial burden and productivity loss as a result of this disease. As well, such an advance will create massive financial and intellectual rewards for New Zealand, especially in the pharmaceutical, scientific, and agricultural sectors. LCT may be poised to make New Zealand the home of the greatest advance ever in diabetes treatment, far greater than insulin, as well as a significant contributor to your nation's economy and global stature.

I will not go over again the massive body of evidence that establishes the safety of this procedure (correspondence from March 2002 onward appended below). It is clear today that such a procedure meets or exceeds the safety standards for clinical trials, and represents virtually no demonstrable risk to the individual or the community. This evidence coupled with the approval by your own government's safety and ethics councils should have allowed the trial to begin long ago.

In your correspondence to me, you have chosen not to counter any of the evidence supporting the safety of these trials or to present evidence of your own regarding the risks. In fact, the only substantive statement you have made suggests what appears to be a rather serious over-reaching of jurisdiction. Specifically, you said in your June 10, 2008 letter to me,

"I consider the spiritual and ethical concerns of the wider population are relevant to my deliberations".

I am sure you agree that a Minister of Health should concern himself only with safety and efficacy, and leave spiritual matters to individual citizens. Should you decide to deny a medical treatment to the broad population based on the spiritual beliefs of a minority, I would suggest that human rights and the separation of church and state have suffered major blows as a direct result of your actions. I trust that your deliberations will consider only the safety and efficacy of the LCT trials, and not dabble in matters of religion.

Perhaps most significant is the fact that these trials have already been approved by New Zealand's safety and ethics councils, based on years of considering scientific evidence and ethical concerns, but continue to be blocked by you. Now in the face of these objective approvals, you are choosing to introduce spiritual considerations to potentially continue the suffering of thousands of New Zealand families, and millions of families around the world, in consideration of an indefinable spiritual -- or possibly, political -- dimension.

Families suffering under the horrors of diabetes will not remain silent in the face of such a denial of their human rights. It is our wish that science should prevail in this situation, but if spiritual, political or other factors are used by your office to prolong the suffering of an identifiable group, then it is our moral duty to assure that voters, including those adversely affected by your actions, understand the reasons for such a tragedy. On the other hand, if you allow science, safety and ethics to prevail, then New Zealanders will know where the credit rightly belongs.

Please forgive my bluntness in addressing this issue, but each day of indecision represents more families struggling to cope with unnecessary blindness, amputation, kidney failure, crippling nerve damage, heart disease, and early death. To justify prolonging this suffering, you have invoked vague spiritual concerns and the threat of risk to the general population despite presenting no supporting evidence and ignoring evidence of safety that satisfied your own regulatory bodies. Those stark realities and the weight of scientific evidence must rank well above any spiritual or political considerations.

We trust that you will not be cherry-picking a few cautionary comments from a sea of favorable evidence in order to justify further delay or a negative decision. The people of New Zealand will judge based on decades of evidence, not on a few minority items selected to support a pre-determined conclusion. Further, the people of New Zealand will not accept negative comments from industry groups such as the International Xenotransplantation Association (IXA), an organization sponsored by the world's largest suppliers of anti-rejection drugs. IXA has fought hard to assure that the billions earned from lifelong toxic immunosuppressive drug therapy are not threatened by LCT's breakthrough in preventing transplant rejection without the use of expensive, toxic drugs. And it goes without say that the arguments of animals-rights and fringe sustainability groups will be seen as the morally inconsistent and unscientific posturing that they are. It is important not to underestimate the intelligence and determination of people who will be adversely affected by a decision, or lack thereof, that undermines their health and human rights, merely to serve the interests of political expediency, fringe advocacy groups, or multinational drug companies.

Please note that continuing delay or an apparent approval that renders the trial non-viable because of scientifically-indefensible restraints will likewise be viewed by New Zealanders as placing politics above their health, economic well-being, and national stature.

Millions of New Zealand voters and families around the world look forward to your nation taking its place as the most significant medical innovator of the new millennium. We trust that you will play an immediate and positive role in ending the scourge of juvenile diabetes, and that the people of New Zealand and the world will recognize the contribution of you and your government to this humanitarian milestone.

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Cheers

SW