NHMRC gives cautious nod to xenotransplantation

A working party of the National Health and Medical Research Council has offered its tentative approval of research involving the transplantation of cells from animals to humans.

But the NHMRC draft guidelines on xenotransplantation, available from today on its web site, still face a period of public consultation before they can be approved.

While the guidelines are not expected to be ratified until early 2003, their authors - a working party drawn from NHMRC ethics and research committees - have tentatively concluded that there should not be a moratorium on xenotransplantation research, but that it should "proceed cautiously under centrally administered guidelines" taking into account ethical issues and the interests of researchers, animal welfare groups and the public.

In a briefing last week, working party chairman Dr Kerry Breen said the guidelines had taken 18 months to draft.

He said there were three main reasons why the NHMRC felt it was important to set guidelines on the research:

• A shortage of donor organs for allotransplantation (human-to-human).
• Scientific breakthroughs suggesting the increased possibility of animal-to-human transplantation.
• Evidence that porcine endogenous retrovirus could be transmitted to humans.

The guidelines take in seven key guidelines: efficacy, safety, openness, consent, monitoring and surveillance, data and tissue storage, and management of public health risks.

If passed in their current form, the guidelines would be the most stringent faced by any Australian researcher.

Working party member Assoc Prof Philip O'Connell, of Westmead Hospital, said the xenotransplantation research community had approached the NHMRC to request guidelines. "We recognised that we would have to address this as a community," he said.

O'Connell said Australia had a high profile in xenotransplantation research, and was home to one of the few companies in the world - BresaGen - involved in pig xenotransplantation. "We're also strong in transplant immunology," he said.

He admitted that guidelines were onerous, "but worldwide that's what people think is required."

Virologist Dr Dominic Dwyer, another research committee representative on the working party, said he felt the research would be easier to do with a set of firm guidelines in place.

He said there was still no evidence for the theory that porcine endogenous retrovirus could jump from pigs to humans, although there was evidence that the virus could infect human cells in laboratory tests.

Working party member Assoc Prof Bernadette Tobin, of the NHMRC's Australian Health Ethics Council, said there was a good reason for setting a high standard for compliance with the guidelines. "The risk-bearers are not just the people who receive the transplant," she said. "The risk-bearers are us - the whole community."

She said she didn't expect the issue to become as heated as the issue of using embryonic stem cells in research, because there were fewer in-principle objections. "We've really made an attempt to think of all the scientific, social, and ethical objections," she said.

In an NHMRC first, the guidelines will be presented to the public in a series of open meetings, set down for three capital cities - Perth, Melbourne and Sydney - next month. "The more public input we receive, the happier this committee will be," Breen said.