Stephen Leahy

BROOKLIN, Canada, Dec 30 2004 (IPS) — Medicine and farming are merging as genetically engineered (GE) maize and soy crops promise cheap drugs, but they also threaten to contaminate food and the environment, warn activists and experts.

The United States has planted very small amounts of these experimental ‘pharma crops’ since the early 1990s, including about 18 ha in 2004, according to the U.S. Department of Agriculture. Although full-scale production is a few years away, a new report is warning that when it begins, the U.S. food supply will be contaminated sooner or later.

"It is sobering that drugs and industrial chemicals could have so many routes to the food supply," said David Andow, the report’s editor and a professor at the University of Minnesota.

The Union of Concerned Scientists (UCS), an environmental non-governmental organisation (NGO) that asked six independent scientists to prepare the report, is calling for an immediate ban on the field production of food or feed crops engineered to produce pharmaceuticals and industrial chemicals.

"Biopharming" is a subset of biotechnology that turns ordinary plants and animals into protein production factories through genetic engineering.

Until recently nearly all drugs were manufactured via synthetic chemical processes. But in the last 20 years the science of biotechnology has led to a new class of drugs called "bio-pharmaceuticals" – therapeutic proteins produced by living cells through microbial fermentation or mammalian cell culture.

The most successful of these has been GE (also known as GM or genetically modified) insulin, which is used by millions of diabetics around the world.

In the early 1980s a human gene for insulin production was stitched into the DNA (the building blocks of the cells of all living things) of the bacteria E coli. With a much lower manufacturing cost, this process completely overtook the traditional source of insulin – the pancreas of cows and pigs.

Thousands of diabetics have experienced bad reactions and many have died as a result of this new GE insulin, called synthetic or "human" insulin, according to the Society for Diabetic Rights.

Despite this, more than 100 bio-pharmaceutical products or "biologics" – serums, antitoxins, vaccines and biological therapeutics ¡- have been approved for use in the United States. Worldwide, another 500 are in clinical trials. These are not always new drugs; many simply replace existing products, like insulin.

The demand for these biologics is skyrocketing, with the market expected to top 56 billion U.S. dollars in 2006 in the United States alone.

However, GE bacterial fermentation systems cost hundreds of millions of dollars to build, require perfect growing conditions and are easily contaminated by other bacteria. By comparison, plants are bargain-basement "bio factories," costing potentially just 10 percent of the fermentation manufacturing process.

GE plants offer the additional advantage of being free of bacteria and viruses that could infect people.

Industry reports indicate roughly 300 companies, including some large pharmaceutical and agriculture-biotech corporations are involved in developing these plant factories.

One of the most ambitious is a European-South African alliance to produce plant-derived drugs for the developing world, including antibodies to prevent HI, the virus that causes AIDS.

Launched in July with 12 million euros in funding from the European Union, the Pharma-Planta Consortium and South Africa’s Council for Science and Industrial Research, backers hope the project’s first product will be a cream containing HIV antibodies to prevent transmission of the virus during sex.

Those antibodies are being engineered into maize in a highly experimental effort in South Africa. Other antibodies for use in a tuberculosis vaccine are also being inserted into maize.

Field trials of the GE crops are two-three years away, while clinical trials on humans are projected within five years.

But cautionary voices warn that the undeniable potential benefits of biopharming to produce life saving, low-cost drugs for the developing world have to be weighed against the risks of the new technology.

Among the first countries dealing with these risks is the United States, but its regulators seem to be in denial, according to Jane Rissler, a UCS scientist.

The U.S. food and drug safety system is considered among the best in the world, and Rissler has no doubt the drugs derived from biopharming will undergo extensive safety testing. However, those responsible for food safety at the U.S. Department of Agriculture (USDA) have not put strict regulations into place to prevent pharmalogically-active proteins from slipping into America’s foods, she said.

And that is despite the fact it almost happened two years ago, when experimental maize plants containing a pig vaccine were accidentally mixed with about 14 million kilograms of soybeans in the U.S. mid-west. ProdiGene, the Texas biotech company responsible for the mishap paid three million dollars in clean-up costs and fines. All of the soy was destroyed.

The USDA tightened its rules after the huge public outcry, which even included the Biotechnology Industry Organisation (BIO), the powerful U.S. biotech industry lobby, asking its members to start growing biopharma crops in more isolated regions.

Companies must now use designated equipment for planting and harvesting, provide better training for growers, and undergo at least five inspections a year. The new rules also require that biopharma maize be grown more than one km away from any other fields and planted at least 28 days before or after surrounding maize crops are sown.

But the new rules are not strict enough, concluded the UCS-sponsored study, released in late December. The bottom line is: it is extraordinarily difficult to prevent contamination.

"Pollen can be carried to fields with food crops by the wind or insects, seeds lodged in the crevices of harvesting equipment could come loose while harvesting food, and plants can come up as volunteers in the middle of a food crop," said report editor Andow in a news release.

The obvious solution is to grow biopharma crops in areas planted in non-food crops, like tobacco, says Rissler.

But that might not happen. Maize is ideal for producing high volumes of proteins, as are soy and rice, and the three are among the most studied plants in the world.

"There is no scientific reason to shift biopharma into non-food crops," says Lisa Dry, a spokesperson for BIO.

"The proteins being grown are well-known and present a low level of risk," Dry added in an interview.

Even though BIO asked its members to grow biopharm maize in non-food producing zones after the ProdiGene incident, it is satisfied with current USDA regulations, which do not require such segregation.

According to Dry, there are hundreds of products in the biotech pipeline, and biopharma products are likely to be commercially available within five years.

Craig Winters of The Campaign to Label Genetically Engineered Foods, a U.S. NGO, predicts, "There will be drugs in breakfast cereals soon or later" because of large-scale planting of biopharma maize.

But even growing them among non-food crops would be unsafe, he told IPS.

Non-food biopharma crops could cross-pollinate with related wild plants and potentially transfer genes that produce the human proteins, he added. And pollen from maize has been documented travelling dozens of kilometres.

"The only safe way to grow these is in non-food crops inside greenhouses," argues Winters.

Dry rejects that suggestion as unnecessary and too expensive. "Greenhouses would need to be several acres in size, which would greatly drive up the cost of production."

But Winters warns that once cross-pollination transfers genes from biopharma crops into non-GE crops or other plants there will be no stopping it. "Those genes can’t be recalled and it would be nearly impossible to clean up."

More darkly, an escaped gene that impairs the world’s ecosystem is not out the realm of possibility, he suggests.

"Biopharma could be an important technology that brings the world cheap vaccines. But it has to be done right."

While environmentalists, the biotech industry and regulators struggle over the potential benefits and risks of this new technology in the United States, there are no regulations and little discussion internationally.

"The FAO (United Nations Food and Agriculture Organisation) has not developed an official position specifically on GMOs (genetically modified organisms) containing biopharmaceuticals and industrial chemicals," Andrea Sonnino of the FAO research and technology development service told IPS.

In general terms the agency supports a science-based evaluation system that would objectively determine the benefits and risks of each individual GMO, including biopharma, Sonnino added in an email message.

But organisations such as the UK-based Institute of Science in Society say international rules are needed quickly to prevent first-world corporations from using developing world countries as regulation-free testing and production grounds.

In the meantime, bans on growing biopharma crops should be put in place by developing countries, the institute recommends.