Dialogue: Evidence shows that pig cell transplants are safe

The Ministry of Health should admit it is wrong about the use of cells from pigs and redeem the hope of thousands for a cure for diabetes, writes NICKI RAFFILLS*.

Dr Bob Boyd, of the Ministry of Health, calls for greater public debate before there is any New Zealand-based research involving the transplantation of pig cells into humans.

What Dr Boyd should realise is that there was great public debate before the first trials happened in 1994. We have had the debate, we have had the initial trials and now it is time to continue with clinical trials under conservative and stringent standards.

I have had diabetes for almost 22 years and have lived my life based around evidence-based medicine. As a 3-year-old, I injected porcine insulin (derived from pigs) and now inject genetically modified insulin to keep me alive every day.

I received a transplant of piglet cells in 1994 as part of Professor Bob Elliott's initial research. This research has now reached a stage where it is removing the need to be on daily injections of insulin.

It has the potential, in the near future, to provide a complete cure for the millions of diabetes sufferers around the world. However, the Ministry of Health is proposing to ban any further clinical trials of this procedure on the basis that it is concerned about the threat of a retrovirus passing from a pig to a human and then to others. This behaviour is not consistent with that of a ministry truly concerned about this threat.

If the ministry is worried about the threat of a retrovirus passing from the pig cells to human cells, it is surprising that it has never contacted me to check on my health and never asked for access to my blood test.

Surely, if it is worried about a retrovirus, it would insist on examining blood samples to see if I had developed such a virus. It has also never contacted me to warn me not to give blood, have children or have sex. This seems to indicate that it is not worried about any threat.

The ministry has also failed to recognise that the safest way to prevent any possible risk of retrovirus is to approve trials in New Zealand and impose the same stringent standards that the Food and Drug Administration has imposed on trials in the United States.

Because clinical trials are banned here, Professor Elliott and his team will move to the Cook Islands. Of course, New Zealanders will fly to the Cook Islands to have the procedure carried out and then return to New Zealand.

This means that any risk of a virus spreading from those who have had the transplant will still be present, but not under the control of the ministry. This behaviour is just not consistent with its stated concern over the risk.

Nor is the behaviour of the ministry, in refusing to argue on evidence-based medicine, consistent with any real concern of retrovirus. If the ministry is concerned about the risk, why does it not ask the world's leading virologists and medical experts for the real evidence?

Instead, Health Minister Annette King and her officials have made misleading comments not based on any scientific truth. It is disappointing to hear Mrs King and Dr Boyd talk of the HIV/Aids virus and compare it to a porcine retrovirus. They may both be a kind of retrovirus, but this is where the similarities finish.

The HIV/Aids virus derives from primates, not pigs, and it is well known that the kind of virus found to exist in humans is closely related to that found in primates. This is exactly the reason why the American FDA has banned transplants from primates but allowed transplants from pigs.

If the ministry were genuinely concerned about the risk of retrovirus, surely it would have investigated the many reputable studies, published in reputable medical journals, that conclude a retrovirus cannot pass from a pig to a human.

At the very least, the ministry would have discovered the research of Dr Paradis, as published in Science, which studied 164 recipients of pig cell transplants and concluded that not one exhibited any evidence of a retrovirus.

If there is any room for further debate on this issue, it should be a scientific discussion based on the research and the evidence available. I'm sure Diatranz would welcome the opportunity to discuss the facts and not the rhetoric the ministry continues to repeat.

The behaviour of the ministry indicates that it is not really worried about the threat of retrovirus. So why has it banned clinical trials of the procedure in New Zealand?

The reality is that the ministry has got itself into a tight corner and cannot get out of it. The ministry, on declining the application of Diatranz to continue clinical trials, realised that it acted unlawfully and that it was wrong.

Instead of admitting that at the time and hearing the appeal of Diatranz, it drafted retrospective legislation that protected its position and saved it the embarrassment of admitting it was wrong.

This is the only explanation for the behaviour of the ministry which is completely at odds with the concept of evidence-based medicine. It is time for the ministry to come clean on this issue and redeem the hope of thousands of New Zealanders of a cure of diabetes in our homeland.

* Nicki Raffills is an Auckland lawyer, one of the six transplant recipients in New Zealand and the third person to have the procedure in the world. She flies to Rarotonga today to speak to the Cook Islands Government.

nzherald.co.nz/health