Is Biopharming Worth The Risk?

The cultivation of genetically engineered plants for industry may save money, but many are being developed in secret and there are already many cases of environmental contamination

By Danila Oder in Los Angeles: 1 June 2003

The latest trend in genetic engineering is to grow modified crops that are not intended for food. 'Pharma' crops are GE plants that produce proteins or chemicals for pharmaceutical and industrial uses. Since 1991, more than 300 open-air field trials of pharma crops have been conducted in the US, although few details have ever been released to the public.

Today, public information is available on only 10% of the 400 products currently being developed by about 20 companies and universities. These products include vaccines, anti-HIV drugs, anti-clotting agents and industrial enzymes. Even the American government is involved - the US National Institutes of Health are now safety testing a corn-grown oral treatment for traveler's diarrhea.

Producing drugs from pharma plants is "potentially much less expensive" than existing methods, says John Howard, Chief Technology Officer of ProdiGene, a privately-owned Texan biopharming company. "But no one really knows what the costs of these products will be. It depends on the expression (the strength of the altered genes) and the purification method."

The benefits vary with the individual drug. For albumin, a widely used medical product made from human blood, biopharming could deliver lower costs and the ability to quickly produce large quantities, says Howard. For products like gelatin and aprotonin - which are sourced from animals - biopharming eliminates exposure to animal contaminants like the rogue proteins responsible for BSE, or 'mad cow' disease. For vaccines and antibiotics, which often require clean needles or refrigeration, pharma crops could be ground or mashed, tested for dose level - and then fed to humans or animals.

This sounds positive, but there are distinct dangers as well. Plants are living beings, and their DNA can impact on the surrounding environment in unpredictable ways. Between 1991 and June 2002, the US Department of Agriculture (USDA) issued over 180 permits and acknowledgments for biopharmed field crops. Over two-thirds were for corn, an open-pollinated crop that has already contaminated both wild corn stocks in Mexico and organic corn fields in the US.

A potential disaster was narrowly averted in November 2002 when a strain of pharma corn plants developed by ProdiGene unexpectedly sprouted in a field of conventional soybeans in Nebraska. The land had been planted the previous year with pharma corn engineered to produce drugs for treatment of pig diarrhea. The soybeans were taken to a warehouse and mixed with 500,000 bushels of non-pharma beans. When the contamination was discovered, the US government ordered all the beans destroyed and the warehouse cleaned.

In a second 2002 incident also involving ProdiGene corn, pollen from Iowa-grown pharma corn may have fertilized nearby food corn. The government ordered about 155 acres burned.

ProdiGene was fined $250,000 and required to pay $3 million for the destroyed soybeans. But the USDA omitted a key fact when it announced the settlement: as reported in the Washington Post on March 26, 2003, the settlement included "payment terms (that are) worth as much as $500,000 in interest and other savings to the company over the next three years."

Even with the stiffest possible regulations, open-air field trials are inherently dangerous. Norman Ellstrand, a plant geneticist at the University of California at Riverside, told New Scientist on November 18, 2002, that the US government had been lucky. "What if the GM corn had come up inside a corn field, instead of a soybean field?" asked Ellstrand. "It could have cross-pollinated and you'd have no idea where it was."

In March 2003, the USDA issued new safety regulations and announced it would begin inspecting each test plot at least five times per growing season, instead of once. Greater distances are now required separating food or feed crops from pharma plants. Growers will now be required to maintain separate storage, planting and harvesting equipment.

This may not be enough. The new regulations have already been criticized as inadequate by anti-GE activists. A coalition of consumer, environmental and farm organizations is currently planning a lawsuit against the USDA to halt the planting of biopharm crops. And the mainstream US food industry doesn't like the regulations either.

The food industry, which generally supports conventional GE crops, remembers what is now known as the StarLink episode. In September 2002, over 600 corn-containing food products were recalled from the US market because of contamination by StarLink corn. The corn had been approved by the US Environmental Protection Agency for use only in animal feed, because of unknown allergic reactions that might be caused in humans. The StarLink affair proved to the food industry and the public that crops like corn and wheat that are transported and stored in bulk, cannot be kept GE-free. Only the prompt recall of consumer products prevented a public-relations disaster for GE food crops.

Many critics wonder why food crops are used for biopharming at all, rather than using non-food crops like hemp, tobacco or a prolific weed like ivy. The reason is that food plants produce fruit or seeds in predictable quantities. Farmers also already know how to grow and harvest them. And US government policies keep the prices of bulk crops low, so many American farmers are desperate for any crop, like pharma plants, that offers a higher profit margin.

To prevent environmental contamination, it would seem sensible to grow pharma plants only in greenhouses. But the business of biopharming - which has high research and development costs - requires the presence of large quantities of extractable drug. That means bulk, or commodity, crops. Two thirds of open air biopharm field trials have been in corn; the other major crops are soybeans, tobacco and rice.

The greatest risk of planting an open-pollinated crop like corn is that of inadvertent cross-breeding with the plant's wild relatives. In Mexico, curious local farmers planted non-pharma GE corn from the US several years ago, despite a national moratorium on commercial planting of GE crops. The contamination was revealed in November 2001 by University of California at Berkeley scientists David Quist and Ignacio Chapela, writing in the respected journal Nature.

Quist and Chapela were attacked by the biotech industry and pro-biotech scientists, and Nature retracted the paper. Nevertheless, on August 26, 2002 the San Francisco Chronicle reported that Mexican scientists at the Instituto Nacional de Ecologia had "repeated Chapela's analysis of the Oaxaca maize and corroborated at least his first assertion, that they contain genetic material from bio-engineered plants."

Following the Mexican corn affair, a US-based, pro-biotech industry journal, Nature Biotechnology, (www.naturebiotechnology.com) pointed out two of the weak links of gene containment: soil and equipment. In a June 2002 editorial, they wrote: "current gene-containment strategies cannot work reliably in the field. Can we reasonably expect farmers to (clean) their agricultural equipment meticulously enough to remove all GM seed?"

Canola, or rape seed, is another open-pollinated GE plant, widely grown in Canada. Recently, the Certified Organic Associations of British Columbia stated that the canola gene pool is now so contaminated that growing organic canola has become almost impossible. On December 29, 2002 the British lndependent newspaper reported that a new British government study had found that GE rape seed was interbreeding on a large scale with conventional crops, as well as breeding and transferring its herbicide-resistant traits to wild turnip, a related weed.

Even controlled reproduction is not enough to prevent genetic contamination from pharma plants. A special report, "Manufacturing Drugs and Chemicals in Crops," issued last July by the environmental group Friends of the Earth states: "gene containment mechanisms such as male sterility and tissue-preferred promoters are known to be 'leaky.'"

Food contamination via food animals presents another serious potential problem, the report warns. "Companies like ProdiGene have also proposed 'dual-use' of biopharm plants - extracting the drug/chemical and then selling the rest for use as food or animal feed," it contends. "Incomplete extraction would mean drug or chemical residues in food products and feeds."

For further details go to www.gefoodalert.org/pages/home.cfm.

People outside the US often wonder why American activists aren't ripping up these fields and why the US public appears relatively complacent about GE experiments and production. One reason is that, unlike in Britain, the European Union and Australia, which publish the precise locations of field trials, US officials only publish the name of the state in which each trial is being carried out. Imagine how hard it would be to find a GE experiment in the state of Texas - which is about the same size as France.

Without open public information, farmers can't determine if GE crops are being grown next door. They can't protect themselves against inadvertent contamination of their crop with GE seeds. There may be potential disasters in the making, and neither farmers nor the public may know until it is too late.