Xenotransplantation: International Standards met?
New Zealand Society for the Study of Diabetes (NZSSD) Executive PRESS RELEASE
21 October 2008
“Proposed Xenotransplantation trial: have International Standards been met?"
The New Zealand Society for the Study of Diabetes (NZSSD) is pleased that a decision has finally been announced by the Minister of Health today on the planned xenotransplantation trial by Living Cell Technologies (LCT).
“Type 1 diabetes is a serious condition that requires sufferers to use injections of insulin multiple times per day. Any breakthrough that can help these people is important” said Associate Professor Patrick Manning, President of NZSSD.
Concern has previously been raised that viral particles found in pigs could be transmitted during this procedure, potentially leading to the public being at risk of novel human diseases.
For this reason it is vital that the xenotransplantation procedure has a high expected benefit before being tested in humans.
Before human studies proceed the likely effectiveness of a technique must be demonstrated in animals. There are international guidelines that should be met before human studies commence.
“Presumably, after careful review of all the evidence in the LCT application, the Minister believes that these international standards have been met. NZSSD has never been privy to this information and will now press for this information to be made available so that it can be satisfied with the Minister’s decision."
The NZSSD Executive is supportive of the Minister’s insistence that a number of caveats be placed on this research trial before it can proceed, one being the establishment of an independent Data Monitoring Board.
“We trust that this Board will have the remit to provide independent oversight of not only the safety but also the effectiveness of this trial. NZSSD will push strongly to be represented on this Board."
The NZSSD Executive regard it as vital that this research is seen to be conducted in an environment of utmost safety, transparency and oversight, so that our international research integrity is maintained. This is in the interest of not only all New Zealanders but also LCT.