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In early 1997, as Dr. Robert Elliott in New Zealand was about to continue his clinical trials of encapsulated pig islets in people with diabetes, the government of New Zealand made the decision to impose a ban on xenotransplantation. Their decision was very puzzling, as one of the factors repeatedly cited was "cultural safety".  Nobody seemed able to define what "cultural safety" meant, except to say that it was more political than scientific. A letter from Bill English, the New Zealand Minister of Health, discusses how issues of "cultural safety" were seen as more important than the health and survival of people with diabetes.   After many months of lost time, the ban has been lifted. You can read the story below.

Tuesday, April 14, 1998
Ban on animal-to-human transplants may be lifted
Landmark work that involved transplanting pig cells into humans to control diabetes is poised to resume, writes ANDREW YOUNG
The country's ban on transplanting animal organs and cells into people is set to be lifted to further world-leading work here. 

A lack of human organ donors has created a huge need to find alternatives, but pioneering research is on hold while new international guidelines are drawn up. 

The United States Food and Drug Administration is due to issue new rules next month, giving approval for studies to continue under stricter conditions. 

Researchers here have shown early expertise in the field, using pig cells in Auckland patients to control diabetes. But an international moratorium was called last year after overseas laboratory tests showed animal viruses could be passed on in transplants. 

That has held up landmark work by Auckland researcher Professor Bob Elliott.  In 1996, he inserted insulin-producing pig cells into two diabetic patients at North Shore Hospital. 

One patient, Michael Helyer, said he understood the caution but had no regrets about being one of the world's few recipients of animal parts.

Up to 30 per cent of his insulin needs were produced by the pig cells after his May 1996 operation. That has made his condition much easier to manage, with fewer low blood-sugar episodes. 

He said insulin produced by the pig cells had since dropped but he hoped for a "top-up" this year if the moratorium was lifted. 

"I knew there were dangers [in receiving pig cells] but I weighed it all up.  There is a lot more risk in having diabetes," he said. 

Diatranz, the company managing the pig cell trials, said New Zealand would stand up to the most rigorous guidelines on animal transplants. 

The managing director, David Collinson, said the work could be huge for the country. 

Diabetic patients worldwide would want to come for pig cell transplants. 

A Ministry of Health advisor, Dr. Stewart Jessamine, said all the risks of animal transplantation needed to be known before research continued. 

"It's very new, it's very cutting edge and very controversial," said Dr. Jessamine. 

"There's no doubt that if you ask transplant surgeons, they will tell you there's an immense shortage of transplant organs and there will never be enough for the demand. 

"I'm sure they would say that it [the use of animal parts] is a good way forward." 

But he said the moratorium on animal-to-human transplants would remain until guidelines were released. 

They were due next month but he had heard that delays were now expected. 

The new guidelines are tipped to include lifetime monitoring of recipients, unprecedented in medicine. 

Animals will also need to be raised in strictly sterilised conditions. 

One fear is passing on organisms harmless to the animal, but disease-causing to people.

Tuesday, April 14, 1998
Pig cells fight Parkinson's disease
NEW YORK - Brain cells taken from foetal pigs and put into human brains have shown early promise in treating Parkinson's disease, a nervous disorder. 

The pig cells were transplanted into the brains of 11 patients, and most improved to some degree, said Dr. James Schumacher, a neurosurgeon with Neurological Associates in Sarasota, Florida. 

The American advance follows a report in the New Zealand Herald yesterday that landmark work involving transplanting pig cells into humans to control diabetes is poised to resume in New Zealand. 

In one case in the American work, a man who had spent most of his time in a wheelchair is "really up and moving... he can play golf again," Dr. Schumacher said. 

The work was designed to look at the procedure's safety rather than effectiveness, said Dr. Schumacher and no major side effects appeared. 

"The patients continually improve. They are not immediately better, but they improve over time as the graft matures." 

He stressed that the results were preliminary. 

Parkinson's disease produces symptoms such as tremors, rigidity and slowing of movement. Medications can help, but often lose effectiveness over time. 

In 1996, Auckland researcher Professor Bob Elliott inserted insulin-producing pig cells (islets) into two volunteer diabetics -- the first project in New Zealand to transplant animal cells into humans. 

Since then a laboratory to prepare pig cells for transplanting into people with diabetes has been set up in Otahuhu by Diatranz  Ltd, a company financing the research project.    - AP

The People Who Decide Our Fate
The Xenotransplantation Debate - Science or Superstition?
International Workshop on Xenotransplantation -- New York City, 18-20 March 1998
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