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NZ:Health committee will consult on pig cell transplants


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8/07/2008 - Health Minister David Cunliffe says the National Health Committee he has called in to advise on plans to implant pig cells into New Zealanders will start sorting out a consultation process on Tuesday.

The committee will give Cunliffe independent advice on an application by Living Cell Technologies Pty Ltd (LCT) to conduct clinical trials of xenotransplantation at Middlemore Hospital in Auckland.

Cunliffe's decision -- the first under amendments to the Medicines Act -- is expected to be a test case for whether the Act
has sufficient safeguards for public health.

New Zealand health regulators blocked initial transplants in 1996 and 1997 by Professor Bob Elliott -- now the company's research leader -- because of fears that the animal transplants could transfer pig viruses into humans.

LCT has already told its shareholders that it expects the committee to report to Cunliffe on August 8.

The biotech entrepreneur last year told its shareholders that it expected approval for the trials to be given in time for it to start
the injections of pig tissue during the last financial quarter of 2007.

It also said in October that putting millions of islet cells from baby pigs into type-1 diabetics did not need wide public
consultation.

But a Wellington thinktank, the Sustainability Council, urged the minister to consult the public on the "community risk" in the
event that transplanted pig tissues triggered an infectious disease in humans.

LCT has said it is already trialling in Moscow the DiabeCellB transplants it hopes to market by 2012 to some of the world's 24
million type-1 diabetes patients.

Health and Disabilities Commissioner Ron Paterson warned in 2005 that individual consent to xenotransplantation research and treatment was "insufficient" and that "collective consent" was necessary.

Cunliffe has asked for the advice under section 96E(1) of the Medicines Act, which says he may only grant such an application if he is satisfied the experiment will not pose an unacceptable risk to the health or safety of the public. It also says any risks must be appropriately managed, and ethical issues addressed.

Cunliffe said interested parties and members of the public will have the opportunity to make submissions on the application, but a spokeswoman for the committee said those hearings would not be open to the media.

Committee staff have already proposed a July 24 date for oral submissions in Wellington.

Source: AAP NewsWire

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