LETTER TO FORMER COOK ISLANDS PRIME MINISTER MAOATE SHOWS HOLES IN PIG CELL

admin's picture

PLANS

By Moana Moeka‘a

AVARUA, Rarotonga, Cook Islands (March 30 2002 – Cook Islands News)---The Health Research Council of New Zealand has pointed out shortcomings in Diatranz Ltd.’s application to conduct live pig cell transplant experiments in the Cook Islands.

In response to a letter from former Prime Minister Dr. Terepai Maoate in January regarding an application from Diatranz to conduct phase 1 xenotransplantation trials of porcine beta-islet cells in Polynesian patients with Type 2 diabetes, the HRC has made a number of comments on the documentation presented.

"The documents, which describe the proposed trial, are based on the submission in 2001 to the NZ Ministry of Health to conduct a phase 1 clinical trials in patients with Type 1 diabetes.

"The study was reviewed by the HRC (Gene Technology Advisory Committee) and did not receive approval to proceed," wrote HRC chief executive Dr. Bruce Scoggins and Associate Professor Ingrid Winship, chair of the HRC (GTAC), in a letter dated January 17, 2002.

"The documents submitted to us for comment are draft and as such contain numerous errors and omissions. A formal review of the proposal could only be conducted on a revised set of documents.

The HRC wrote that the documentation did not address how the clinical trial would be done in Rarotonga.

"As written, it describes a trial to be conducted at North Shore Hospital in Auckland.

"The documentation fails to provide a convincing rationale as to why xenotransplantation is an appropriate treatment for Type 2 diabetes, a disease characterized by insulin resistance."

The papers provided by Diatranz did not mention the results of the clinical trials conducted in Mexico during 2000/01, said the HRC.

The HRC made three recommendations regarding the review of the Diatranz documentation, but only from a scientific and safety perspective.

"If a decision was made that there was adequate justification, based on the scientific review, to proceed then the proposed trial would need to be reviewed by an ethics committee. If the Cook Islands Government were to need assistance in this regard, the HRC Ethics Committee would be available to provide assistance."

The recommendations by the HRC were:

• That the Cooks could follow New Zealand’s lead to place a moratorium on xenotransplantation studies in humans pending the outcome of future pre-clinical research.

• That the government ask the HRC directly or via the NZ Ministry of Health, to review the proposal submitted by Diatranz.

• That a third party country be asked to conduct the scientific review of the proposed trial.

"We look forward to your comments on our recommendations. Please do not hesitate to get in touch if you need additional information. We have been working on xenotransplantation for the past four years and have an extensive bibliography on the technology," said Dr. Scoggins and Associate Professor Winship.

The Cook Islands government announced recently that they are still at the primary stage of conducting "due diligence" on the project. They say only the implant operations would be conducted at Rarotonga Hospital and the patients, all of whom would be Cook Islanders living in New Zealand, would be sent back to that country.

Type 2, or non-insulin dependent diabetes is common in adult Cook Islanders and it is brought on by eating the wrong food, lack of exercise or excessive alcohol consumption.

An article by Jeffrey L. Platt on islet xenotransplantation for the Journal for Clinical Investigation was read over the Internet by a Rarotonga resident and sent to Cook Islands News.

In his 1998 paper, Platt said that although islet xenotransplantation had been accomplished in rodents, there was evidence that the humoral reactions, which in human and primates "would cause devastating injury to organ xenografts, may, under some conditions, arise in response to and potentially limit the function of islet xenografts.

"One question which must be addressed before widespread application can be undertaken is whether the xenogeneic islet implants will fully restore the normal regulation of blood sugar," Platt wrote.

Meanwhile, an article in the February 2002 Pacific News Bulletin told how Tongans opposed plans by an Australian bio-tech company, Autogen, to access and compile their gene pool in a database.

"Three centuries ago they came for sandalwood. Today the bastards are after our genes," said Lopeti Senituli, director of the Tonga Human Rights and Democracy Movement when attending a bio-ethics conference in Australia last month.

Autogen signed an agreement with the government of Tonga — without any public debate — to formulate research involving voluntary collection of gene samples. In exchange for the genes, reported PNB, Tonga would receive a new research facility, a health database, royalties or profits from the research, and free treatment for Tongans.

However, with widespread opposition to Autogen’s plans, which Senituli said amounted to "bio-piracy," the company has said that it has decided not to push ahead with the Tonga research.

For additional reports from the Cook Islands News Online, go to PACIFIC ISLANDS REPORT News/Information Links: Newspapers/Cook Islands News Online.

Rate this article: 
No votes yet

Add new comment