Fear, regulatory black hole block diabetes trials

Stringent guidelines and incomplete regulatory guidelines at home are forcing Australian and New Zealand biotechs offshore to test their novel diabetes treatments.

But they are discovering that not everyone wants them.

Last week, the Cook Islands government deferred a proposal by Diatranz, a New Zealand-based biotechnology company, to begin trials of the diabetes treatment in which pig pancreatic tissue is transplanted into humans through xenotransplantation.

Diatranz' Cook Islands xenotransplantation trial was knocked back after the Pacific nation's government expressed "serious concerns" that the company was rushing headlong into a situation that it could not control, government officials said in a statement.

The government said that the Cook Islands did not possess the infrastructure to control sophisticated medical experiments, and that it was concerned about viruses passing from pigs to humans.

But Diatranz claimed that its previous trials, carried out in Mexico on 12 teenagers, fully cured one 18-year-old girl of diabetes and reduced by half the need for daily insulin injections for five others and to a lesser extent in the remaining patients.

Company scientist Prof Bob Elliot said that an alarming number of Cook Islanders, like many Pacific peoples, suffered severe diabetes that could not be cured, and that the disease was extremely expensive to treat.

"The impact of diabetes is greater than cancer and is probably the single most underestimated cost in medical care in New Zealand," Elliot said. More than 40 per cent of New Zealand's Polynesian adults over 40 years of age suffered from diabetes, and the incidence would double by 2025, he claimed.

The Cook Islands government banned the use of pig cell transplants to treat Type I diabetes, but said it was still deciding whether trials for Type II diabetes would go ahead.

Meanwhile, Australian scientists are also going offshore to trial use of pig cells in diabetes treatments.

Researchers at the Diabetes Transplant Unit at Sydney's Prince of Wales Hospital have set up a research arm in Singapore to trial pigs islet cells in non-human primate models.

"We were ready to go ahead with it [in humans] a year ago," said researcher Tracy Ellison. "We have the system set up.

"Every two weeks we are isolating cells from pigs and they are going into research animals, but we believe they are ready to go," she said.

Ellison said that hundreds of diabetes patients had received a form of xenotransplantation in the US, following Food and Drug Administration guidelines.

Patients had been treated using transplanted pig cells or profusing a patient's blood through a pig liver, she said.

"You cannot do this research in Australia at the moment," she said. "We are waiting for [the NHMRC] to develop a system that would regulate xenotransplantation," Ellison told Australian Biotechnology News.

Prof Ron Trent, chairman of the NMHRC's Gene and Related Therapies Advisory Panel (G-TRAP) which was set up only 12 months ago, said that the NHMRC did not have guidelines for Xenotransplantation.

"But we are providing advice on the overall risk-benefit analysis," he said. Trent said that no human xenotransplantion research had been approved, for a number of reasons including the benefit to patient versus the risk to the community and the source of pig tissue.

There was an unknown risk of viruses passing from pigs to humans, Trent said. Dr Kerry Breen, Chair of the Australian Ethics Committee at NHMRC, said new guidelines for xenotransplantation would be signed off by the NHMRC later this year.

Breen, who also chairs the NHMRC working committee on the guidelines, said he was putting final touches to the paper and its ethical, social, scientific and technical issues regarding human xenotransplantation, and that it would be out for public consultation in May.