KEY POINTS:
The Auckland scientist who pioneered pig-cell transplants to treat type 1 diabetes has threatened to give up plans for a trial at Middlemore Hospital if the Government continues to delay its regulatory approval.
Professor Bob Elliott, the medical director of Living Cell Technologies, announced successful interim results -
from a Russian trial - at an international diabetes conference in Wellington yesterday.
Of the four patients who had been given laparoscopic transplants of millions of specially encapsulated cells from the pancreas of neonatal pigs, one had been able to give up insulin injections for five months and for the sixth month needed only a tiny daily dose.
"It's a very durable effect," said Professor Elliott.
Around 15,000 people in New Zealand have type 1 diabetes, an auto-immune disease that leaves the person unable to produce insulin - needed to process glucose - and therefore reliant on regular injections of synthetic insulin.
Professor Elliott warned that Living Cell would give up hope of running a trial in New Zealand if Health Minister David Cunliffe, who took over responsibility from predecessor Pete Hodgson for deciding on the trial, did not give his consent soon.
"There's a real prospect here that if we can't do it here we will do it in Denver. We can't be held hostage to further delays," Professor Elliott said.
Living Cell has applied to the United States Food and Drug Administration for approval to run a trial in Denver.
The company is listed on the Australian stock exchange and has a market capitalisation of about A$66 million ($76.3 million), but its processing facilities are in South Auckland.
Its proposed trial at Middlemore attracted last-minute opposition in October from the Sustainability Council, which said there should be widespread public consultation before the trial was approved, because of the risk that pig cell transplants could transfer pig viruses to humans.
The Russian trial has found no evidence of pig-virus transfer after tests were done on the patients.
For the New Zealand trial in eight patients, the company gained the last of the approvals it needed last year - except the minister's, which was widely expected in December.
"We've got scientific, cultural, spiritual [approval], manufacturing laboratory certification all ticked off, and recommendation from the Ministry of Health," Professor Elliott said.
"It's been on the minister's desk [Mr Hodgson's, then Mr Cunliffe's] for six months. We are very disappointed by that, given that all the necessary approvals have been sought and gained."
Professor Elliott added: "This could be a very significant industry for New Zealand. There are 20 million type 1 diabetics in the world and quite a few of those would be willing to come to New Zealand and have a transplant, which is the way it would go if it got going and went well.
"The possibility of it would be removed if we hadn't done the trials here. It would happen in the States.
"They would get the benefit, rather than New Zealand."
Mr Cunliffe said that while he appreciated Living Cell's frustration, it was important that all relevant information be considered before a decision was made.
"I have taken my responsibilities regarding this application extremely seriously and will not make a decision until I feel comfortable that I have seen and considered thoroughly all the information.
"That decision needs to take into account a wide range of factors, including clinical risk and benefits ... [and] stakeholder concerns, including cultural, spiritual and ethical interests."
RUSSIAN RESULTS
* Four adults with type 1 diabetes have received small-dose transplants of specially encapsulated cells from the pancreas of newborn piglets.
* No anti-rejection drugs are needed.
* Two of the patients have shown a significantly reduced need for insulin injections.
* The third patient's insulin needs increased, but for personal reasons that led to his eating more, not because of the treatment.
* The last patient received her first implant in February and her insulin requirement was reduced by 10 per cent by just four weeks later.
* No evidence was found of pig-virus transmission to humans.
Hunt for mystery hormone to aid fight against disease
New Zealand researchers are hunting for a mystery hormone they believe is the reason obesity surgery halts diabetes in 85 per cent of diabetics.
Stomach surgery to allow the dangerously obese to shed around a third of their body weight is expensive - about $15,000 - and few get it through the public health system.
But a national committee is evaluating whether access in the public health system should be increased. Separately, the Counties Manukau District Health Board, which has about 29,000 "morbidly obese" people in its catchment, is offering the surgery to 100 patients over 12 months as part of a study.
Yesterday, Wellington surgeon Richard Stubbs, of Wakefield Hospital and the Wakefield Gastroenterology Research Institute, described the hunt for "substance X" and the diabetic benefits of obesity surgery to an international diabetes conference in the city attended by around 2000 people.
He said 85 per cent of diabetics who had gastric bypass surgery were cured of their diabetes soon after, typically within a week. A further 10 per cent experienced an improvement in their diabetes.
These benefits could not be related to weight loss, because the diabetic changes occurred before the weight loss. Nor was it related to reduced energy consumption, he said.
A study presented at the conference by diabetes specialist Dr Jeremy Krebs, in which Mr Stubbs was a researcher, shows that insulin sensitivity, a marker of diabetes, reduced more in patients who had had the surgery than in those who were on a very-low-calorie diet.
Mr Stubbs said that after gastric bypass surgery, food went into a small pouch from the stomach and bypassed the first part of the small intestine, called the duodenum.
His group was one of several in the world looking for a hormone produced in the duodenum that prevented insulin from working properly in the processing of glucose by the body's cells - the mechanism of diabetes.
Mr Stubbs said that if substance X could be identified, a medicine could theoretically be developed to counter its effect on insulin sensitivity.
But Counties Manukau diabetes specialist Dr Brandon Orr-Walker was sceptical about the search for substance X. He questioned the need to look for it, when the surgery worked well for so many diabetes patients.
"I'm intrigued why people are looking for a hormone when the effect seems to be so strongly related to weight loss."
Wellington Hospital diabetes specialist Dr Robyn Toomath said several hormones related to eating and obesity had been found and Mr Stubbs' idea of one from the duodenum being involved in insulin sensitivity was plausible.
The only sure ways to fight obesity were public health messages and surgery for those suffering the health consequences of being too heavy.
