The European Union is sponsoring a new initiative aimed at producing pharmaceuticals in genetically modified crop plants such as maize, and hopes to start the first clinical trials of a product by 2009. But the news has been met with dismay by environmentalist groups, alarmed that the GM traits could find their way into the food chain.
The consortium of European scientists, called Pharma-Planta, is planning to produce vaccines and other treatments for major diseases, such as HIV/Aids, rabies, diabetes and TB, and will be backed to the tune of €12 million by the EU.
Making pharmaceuticals in crop plants is an attractive proposition because they are inexpensive to grow, and could produce vast quantities of drugs or vaccines at low cost, potentially making it possible to make drugs that were not economically feasible before. But the rapid timeframe of the new project has raised fears that the safety aspects of the technology will not be adequately explored.
Speaking at a press conference in London earlier this week, the administrative coordinator of the project - Prof Rainer Fischer of the Fraunhofer research institute in Germany - said that the project was wide-ranging and would cover the human and environmental safety aspects of crop biomanufacturing.
But environment groups such as Friends of the Earth are appalled at the prospect of field trials of GM crops carrying pharmaceutically active payloads.
Claire Oxborrow of FoE said that food crops in the US have already been destroyed because of contamination by experimental pharma crops. She cited a case in 2002 where a soy crop had to be destroyed after it was discovered to have taken up a transgene - used to produce a pharmaceutical or industrial chemical - from soy that had been planted on the site the previous season.
"A clear set of criteria must be established to ensure that human health and the environment are protected," she said.
Prof Philip Dale of the John Innes Centre in the UK stressed at the press conference that the risk of GM traits getting into food plants was a concern, and suggested that non-food crops such as tobacco or maize might be one way around the problem, although "careful evaluation will have to take place before a decision can be reached."
But FoE is particularly concerned about the potential use of maize, as the consortium is looking at production sites within the EU and South Africa - and in the latter country maize is a staple crop. Pharma-Planta maintains that the crops will be grown on dedicated plots, surrounded by 'buffer zones' and isolated from food crops, and would all be male, sterile plants that do not produce pollen.
Lower costs could help developing world
The scientific co-ordinator of Pharma-Planta, Prof Julian Ma of St George's Hospital Medical School in London, noted that the technology will "undoubtedly help to make previously unavailable drugs accessible to the developing world."The fruits of the research will be freely licensed in those countries, according to Pharma-Planta.
The consortium's first product, possibly grown in maize, is likely to be an antibody that can be used to block HIV transmission, a major problem in sub-Saharan Africa which has the highest rate of HIV/AIDS in the world with more than 30 million affected. It would be incorporated into a microbicidal cream that could be used in the vagina.
The second product will probably to be a post-bite vaccine for rabies, which is still a significant killer in Africa and Southeast Asia. The viral disease is responsible for 40-70,000 deaths per year, mostly in children.
Ma said the programme had the potential to address the serious problem of global inequity of health, given that the major burden of disease is in developing nations where access to many vaccines is very poor.
"The current methods used to generate these types of treatments include genetic modification of human cells and microorganisms such as bacteria. These techniques are labour intensive, expensive and often only produce relatively small amounts of pharmaceuticals," he said, putting them out of reach of many developing nations.
A report on the crop biomanufacturing sector, published earlier this year by Bio-Era , found that crop biomanufacturing has significant advantages in production costs over rival systems, as crops are already produced by a 'competitive and efficient agricultural-industrial complex', and the capital needed for new production capacity is much lower than for mammalian culture or fermentation.
This report also revealed that the vast majority of field trials of biomanufacturing in crops - 90 per cent - have been in food plants such as soy, barley, rapeseed, safflower, sugarcane, tomato, and wheat. The reason is that much more R&D has been carried out on manipulating the genes of these crops by the agricultural biotechnology sector compared to non-food crops such as tobacco and alfalfa.
Another consideration is that tobacco and alfalfa need immediate processing after harvesting, while a number of food crops can store the recombinant biomolecule in their seed, allowing it to be stored and shipped before processing.