FOCUS ON AFRICA
http://www.gmwatch.org/africa.asp

EXCERPTS: Organizations like GM Watch accuse biotech companies and industry-sponsored groups of browbeating African governments into accepting weak safety regulations, while aggressively mounting slick PR campaigns to force their products on an unsuspecting population. Despite its noble-sounding intentions, the Pharma-Planta project is merely the next step in industry's GM conquest of Africa, they say.

"We have an appallingly weak and opaque regulatory regime, that is devised more to facilitate the introduction of GMOs than to regulate them," - Glenn Ashton, co-coordinator of South Africa's SafeAge
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Pharms Take Root in South Africa
By Megan Lindow
WIRED NEWS, Oct 20 2004
(for all the links embedded in this article, go to) http://www.wired.com/news/medtech/0,1286,65401,00.html?tw=wn_tophead_3

CAPE TOWN, South Africa -- Most people probably wouldn't associate the leafy green tobacco plant with saving lives. But to Dr. Blessed Okole, the maligned cash crop is a potential gold mine of affordable medicine and vaccines for the overlooked diseases afflicting the developing world.

In the laboratories of the Council for Science and Industrial Research, or CSIR, South African researchers are honing techniques for turning genetically engineered tobacco and other crops into factories for producing drugs for HIV and tuberculosis. With a bit of genetic engineering, Okole says, plants' cellular machinery can be tweaked to produce antibodies on a large scale and far more cheaply than conventional drug-manufacturing methods allow.

"We feel it is going to be cheaper to produce the drugs in plants, and also easier for local communities in Africa to have access to them," says Okole, who is business area manager of the CSIR's plant biotechnology group.

This practice, called "pharming," could dramatically boost the availability of drugs in the developing world, Okole says. This is the stated aim of the Pharma-Planta Consortium, a European research group and CSIR partner. Launched in July with 12 million euros in funding from the European Union, the project hopes to produce plant-derived drugs ready for clinical trial within five years.

Scientists with CSIR are already working to produce in plants two antibodies that scientists have found -- one that neutralizes HIV, the other tuberculosis.

The first product -- which will probably be grown in maize plants -- is likely to be a cream containing antibodies to HIV, which could be used to help prevent transmission of the virus during sex. But the technology is still highly experimental.

The first field trials are still several years away, Okole says.

Nevertheless, proponents of pharming are touting the technology as the latest genetically modified form of salvation for Africa. Around 3.3 million people die each year from diseases for which vaccines are available. But the high cost of producing vaccines -- roughly $100 million to get to the clinical trial stage -- is often a barrier to new research on diseases that primarily affect the poor.

"There's a pile of so-called orphan vaccines, where the potential to make a profit is almost minimal," says professor Ed Rybicki, who heads the Plant-Based Vaccines Group at the University of Cape Town. "The big companies are not getting involved because people in Alabama don't need them, but people in the Sudan do."

Increasingly, African countries are developing biotech facilities that will enable them to manufacture plant-based vaccines themselves -- at somewhere between a tenth and a hundredth of the cost of conventional vaccines, researchers say.

Making large quantities of vaccines by normal fermentation or cell-culture methods is difficult, and distributing them to remote areas is a challenge because they require refrigeration. Plant-based pharmaceuticals should solve both problems, since the plants will in theory produce these complex pharmaceutical compounds as part of their regular growth cycles.

In addition, plants are able to produce large quantities of proteins, says Rybicki, which means that pharming should most likely be small-scale. A mere 2.5 acres of tobacco will produce enough vaccine protein for 4 million doses, he says.

The prospect of pharming in Africa alarms local anti-GMO activists, however. After a local newspaper reported that the CSIR had offered to grow the first field trial crops in South Africa -- safe from the angry scythes of European protesters -- local activists denounced the project, charging that South Africa is being used as a dumping ground for unsafe technology.

"We have an appallingly weak and opaque regulatory regime, that is devised more to facilitate the introduction of GMOs than to regulate them," wrote Glenn Ashton, co-coordinator of the anti-GM group SafeAge in a letter to the editor. "This appears to be yet another case of shifting another dirty industry to a developing nation so that we bear all of the risks, while the northern developers reap the genetically engineered fruits."

Organizations like GM Watch accuse biotech companies and industry-sponsored groups of browbeating African governments into accepting weak safety regulations, while aggressively mounting slick PR campaigns to force their products on an unsuspecting population. Despite its noble-sounding intentions, the Pharma-Planta project is merely the next step in industry's GM conquest of Africa, they say.

One of the greatest concerns with pharming is that bioengineered food crops like maize -- which is a staple for many Africans -- will mix with normal crops, contaminating the food supply. Certain pharmaceutical proteins in plants could prove toxic to people if they are touched or eaten.

"For us it seems inevitable that there will be cross-contamination," says Haidee Swanby, a spokeswoman with the organization Biowatch. Pharming could easily be carried out in inedible plants as well, but Okole says the CSIR has considerable experience working with maize already, and the plant is known not to be toxic to humans.

To the chagrin of environmentalists, South Africa has emerged as one of the world's keenest adopters of GM technology, approving hundreds of field trials and importation permits for GM food and crops, including most recently a controversial U.S. project to grow GM potatoes. In addition, a national biotechnology strategy commits roughly $70 million toward developing the local sector over the next three years, identifying biotech as an important means of addressing the country's development needs in areas such as drug research.

The rest of the continent is following suit. The first of four bioscience "centers for excellence" will soon open in Nairobi, as part of an initiative of The New Partnership for Africa's Development to promote scientific research on the continent, for example.

Capacity in Africa to produce and regulate pharmed and other GM crops is now limited, Okole says. But as Europe and North America offer funding and expertise, this gap could narrow within a decade, he says.

Unlike in Europe, however, the locations of GM field trials are kept secret in South Africa, making it impossible to monitor biosafety, Swanby says.

Earlier this year, Biowatch filed a lawsuit against the Department of Agriculture and Monsanto, demanding greater transparency in the process of granting permits to grow and import genetically engineered food and crops.

Scientists agree that strict oversight is necessary, but insist that the dangers of biopharming are small.

It is also likely that pharma crops will be grown in contained greenhouses, rather than in open fields, further reducing the risk of contamination, says Rybicki.

But Swanby says the public simply needs more information about the risks. "People will say, 'How can you deny Africans cheap medicines?'" she says. "That's not what we want to do, we just want all of the information in front of us."