Pig cell transplants gain initial approval from Cook Islands' Govt

By ANGELA GREGORY health reporter

An Auckland-based research company hopes it will soon start controversial clinical trials involving the transplantation of pig cells to humans after gaining initial approval from the cabinet of the Cook Islands' Government.

Diatranz, a diabetes research company, wants to run trials in the Cook Islands after the Ministry of Health rejected plans to hold them in New Zealand.

Diatranz medical director Dr Bob Elliott told the Herald from Rarotonga the trials were unanimously supported by all members of the Cook Islands cabinet today.

Dr Elliott said the cabinet had asked him to now consult with Cook Island interest groups and that should be completed by the end of the week.

Dr Elliott said he had already met with the doctors and nurses at the Rarotongan hospital, and they seemed supportive.

"It went very well ... they asked a lot of interesting and very informed questions."

Dr Elliott said he was told most diabetes in the Cook Islands would want to be treated.

"And they don't seem to worried about the retrovirus."

In New Zealand the ministry's chief adviser on safety and regulation, Dr Bob Boyd, had questioned the ethics of the plan to transplant insulin-producing pig cells into the bodies of 24 Cooks diabetics.

Dr Boyd said the potential benefit for diabetics had to be weighed against the risk of infecting the whole human population with pig retroviruses through body fluids.

Dr Elliott said he would tomorrow meet with more Cook Island groups like the Chamber of Commerce and the Church Council.

A huge public meeting would follow on Friday.

Dr Elliott said he was aware of some opposition.

"Quite a few people have voiced an adverse reaction, people who don't have diabetes ... it has been translated to me that they are traditionalists, holding old values."

Dr Elliott said should no major obstacles arise from the public consultation he expected the cabinet to given the "green, green light" and trials could begin in May or June.

"We already have some volunteers on board."

Dr Elliott was dismissive of a letter sent to the New Zealand Minister of Health, Annette King, from the International Xenotransplantation Association (IXA) which expressed a "deep concern" about the activities of Diatranz.

The IXA president elect, Tony d'Apice, said a statement made by the association in response to trials by Diatranz in Mexico was to be published in the scientific journals Transplantation and Xenotransplantation.

In the Mexico trials pig cells produced insulin in the bodies of some teenagers.

Mr d'Apice said IXA was an international association of several hundred members from most developed countries who were interested in seeing xenotransplantation become a successful clinical treatment for organ failure.

But the association said in its statement it was concerned about the risks of infections from the pigs spreading into the human population.

This risk had to be weighed against the possible benefit to the recipients.

"It is our opinion that the studies of possible benefit are inadequate and do not counterbalance the potential risks involved. Demonstration of effectiveness of the treatment in studies performed in non-human primates is required before human trials are justified."

IXA believed the risks could only be regarded as manageable if proper monitoring of recipients and family contacts could be undertaken on a long term basis.

"I can not imagine that the Cook Islands have the sophisticated virology facilities needed for monitoring for pig viruses, bacteria etc which might infect humans."

Jurisdictions like Mexico and the Cook Islands did not have appropriate regulatory authorities to develop appropriate guidelines to safeguard the patients and their contacts.

"One suspects that the reason that trials are conducted in such countries is precisely because they do not have such safeguards."

But Dr Elliott called IXA a modern version of the flat-earth society.

He said it was racist to imply the Cook Islands were a "crummy place" for the research.

"This is just flim-flam ... by a group of extremists."

Dr Elliott said the diagnostic procedures would be carried out in New Zealand laboratories.