PPL was catalyst for GE livestock in NZ

By KENT ATKINSON

When environment minister Simon Upton in 1995 refused the first PPL Therapeutics application to engineer sheep to carry human gene codes, the company said the decision was political.

PPL Therapeutics' then senior scientist Ron James said it appeared the minister's advisers had rejected the application because they feared it could cause a backlash against genetically engineered (GE) organisms in New Zealand.

In fact, Mr Upton's advisers said the proposal for the breeding and export of transgenic sheep had actual or potential risks outweighing the benefits which might accrue to the nation.

But although the minister said there was no objection to genetic engineering, with the appropriate controls, he appeared to have been heavily influenced by the tone of a conference organised in July 1995 by the Health Research Council at which Maori activists strongly criticised the "arrogance" of genetic scientists.

Later Mr Upton said the ethics surrounding the introduction of GE organisms and other aspects of biotechnology had to be handled with care.

"Public concern about genetically modified organisms could close down a large chunk of New Zealand research if we didn't get a proper public understanding and good-quality risk-management procedures in place, to reassure people," he said.

The message reached the unsuccessful applicants. After meeting some members of the Environment Ministry's interim assessment group -- the predecessor to today's Environmental Risk Management Authority (Erma) -- Dr James said it was "their belief that the assumed negative public reaction to the acceptance of our proposal would have had a knock-on negative effect on the development of transgenic science in New Zealand".

"This was ... the sole basis for the application being refused."

Eventually PPL did get its permission through the interim group and used semen from transgenic rams at East Mains in Scotland on 100 New Zealand ewes in quarantine at Whakamaru, in a bid to breed 40 GE rams to be used in the foundation flock. By May 1996, it had permission to buy a 58ha farm for the sheep.

A year later, it had a Massey University senior research assistant collecting cells from lambs to establish a cell line at Massey for cloning whole flocks of sheep.

Mr Upton was widely seen as trying to defer such controversial applications until a more transparent process was put in place with the Hazardous Substances and New Organisms Act 1996 (Hasno).

In fact, when Erma started public hearings in November 1998 on GE organisms, it started with relatively non-controversial applications, such as for sugarbeet.

But a month later, its third public hearing, was on PPL's application of a full-scale "field trial", Erma's first involving GE animals.

PPL said it was planning to produce human alpha-1-antitrypsin (AAT) from the sheep milk, and targeting a global market potentially worth $2 billion for treatments for cystic fibrosis and for some congenital emphysema. Dr James said the milk would be refined to produce a tonne of product a year, with pharmaceuticals estimated to be worth between US$100/gram and US$200/g.

The sheep had been modified with copies of human genes from a Danish woman, though Erma's Maori advisers said human genes in animals should not be allowed.

A critic of PPL's use of the technology, scientist Dr Robert Mann, said previous medical trials of AAT overseas had only limited success.

Erma's Maori advisory committee, Nga Kaihautu Tikanga Taiao slated PPL's talk of charging patients as much as $40,000 each annually, and questioned whether it would develop any widely used cure for cystic fibrosis or congenital emphysema.

The claimed incidence of one-in-3000 for cystic fibrosis in Caucasians seemed relatively low, so it was unlikely the research would be of major benefit to humankind. Any drug resulting from the research was likely to be expensive "and therefore unaffordable to indigenous peoples".

The PPL had 147 transgenic sheep in New Zealand when it was given the go-ahead in March of 1999 for large-scale breeding of GE sheep. Dr James said he wanted to lift the flock's size, first to 1000 ewes and later to 10,000. It had already gained permission to buy another 93ha of land at Whakamaru and in 2000 would boost that with a further 20ha.

PPL said at the time it was also working on commercially producing human protein which could be used to seal wounds or stop bleeding, Fibrin 1 -- now its sole remaining commercial product -- and BSSL (bile salt stimulated lipase) an enzyme that broke down fats.

A naturally occurring human enzyme that is produced in the pancreas and in breast milk, BSSL breaks down lipids for digestion, and has been claimed by PPL as likely to help patients with cystic fibrosis and chronic pancreatitis digest their food.

It could also have been added to formula milks made from cows milk or soya to boost the weight-gain of premature infants, according to the company, which last month told Whakamaru residents it wanted to genetically engineer local sheep to produce it.

But analysts in Britain said on Friday the BSSL project was not likely to go ahead. And the future of the New Zealand farm and its GE sheep would depend on whether the company's assets were broken up, the company and its intellectual property were sold off as a going concern, or it continued with its single commercial product, and kept the GE sheep mothballed.

PPL announced it was laying off 90 per cent of its staff -- between 90 and 140 jobs in Edinburgh and New Zealand.

Up in the air are the jobs of 17 New Zealand employees -- nine farmhands and eight administrative staff.

- NZPA