- 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
The United States has planted very small amounts of these experimental
'pharma crops' since the early 1990s, including about 18 hectacre 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
organization (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
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
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
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
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 Organization (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
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 traveling dozens of kilometers.
”The only safe way to grow these is in non-food crops inside greenhouses,”
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
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 Organization) 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 organizations 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
In the meantime, bans on growing biopharma crops should be put in place by
developing countries, the institute recommends.
© Copyright 2004 IPS - Inter Press Service