Human Genes for Milky Medicines

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Farmers know a thing or two about milk in New Zealand's Waikato region, the lush part of the North Island that has more cows than anywhere else in the country. But they won't have encountered anything quite like the calves that are due to be born in a research facility there in late 2003. A decision by New Zealand's genetic-science regulator on Oct. 1 means the calves will have human genes-and that their milk will contain human proteins that may be used as medicines.

That's a highly contentious step in New Zealand, where suspicion of genetic engineering led to a moratorium on the release of GM organisms that won't be lifted until next October. But the Environmental Risk Management Authority has given AgResearch-a government-owned research and development company-a seven-and-a-half year license to develop cattle with a range of genes from humans, mice, cattle, sheep, deer and goats.

Initially, says AgResearch ceo Keith Steele, the project will focus on three human genes, though up to 200 cattle- each with a single introduced gene-could eventually be housed at the company's secure containment facility in Waikato. It will be the country's biggest foray into transgenic cattle, though not its first. AgResearch already has six GM calves-due to come into milk in the next few months-with a gene for the human-myelin basic protein, which it says could one day be produced in commercial quantities of milk to treat multiple sclerosis.

Many such proteins can already be produced or extracted from human tissue, but costs are high and the quantities low. Cows, on the other hand, could produce large quantities of protein-carrying milk from which it's hoped medicines could be extracted and purified. AgResearch claims its project will be the most advanced of its kind. But in the ruling, erma imposed extra controls, allowing only one generation of breeding, the use only of genes with a known function, and the banning of genetic material linked to antibiotic resistance or spongiform encephalopathies such as mad cow disease. The project's benefits, said erma, outweighed the risks to the environment or people, 'although this is ... a matter of judgment, given the difficulty of quantifying risks, costs and benefits, and the impact of uncertainty."

Of 863 submissions to the agency, only seven supported the project. AgResearch's Steele says many fears are ill-founded: 'There's a mixture of fact and fiction and postulating."But Peter Wills, an Auckland University biologist and longtime critic of genetic engineering, predicts a legal challenge. 'This is a major ethical step,"he says, 'and there's not been adequate discussion about the radical new character of the relationship between human beings and the rest of biology."The humble glass of milk may never look the same.

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