
Aaron Zitner L.A. Times June 4, 2001
OMAHA--Stepping over the stubble of last year's cornstalks, Barry
Wiggins used a measuring wheel to pace off an exact acre of farmland. He
marked the plot with orange flags, then used a hand-held gizmo to take a
satellite reading of its precise location on Earth. Only then did Wiggins
rip open a bag of seed corn and pour it into the planting equipment that sat
behind his tractor.
When the corn sprouts here, it will not look like anything special. But
the federal government is requiring unusual measures to mark this field
because this corn is not intended for anyone's dinner plate. Instead, it has
been genetically engineered to produce a pharmaceutical: a protein being
tested as a vaccine for hepatitis B.
For the gene revolution, this looks to be the next big step: turning
plants into factories to make drugs and industrial chemicals. And for a
world already sorting out its views on genetically modified foods, the
coming wave of crops adds new and urgent questions about the practice of
tinkering with genes.
Already, human trials have begun on "edible vaccines" grown in
genetically engineered corn and potatoes. Building medicines into cornflakes
or other foods could be especially helpful for developing countries, where
syringes, refrigeration and trained medical workers often are scarce.
"There's no doubt that this could be very important," said Jose Luis Di
Fabio, an official with the Pan American Health Organization. About 1.6
million unvaccinated children die each year of diseases for which vaccines
exist, he said.
U.S. farmers also could benefit, as companies promise to pay a premium
for growing the new plants. In a bid to help ailing tobacco farmers,
Congress and the state of Virginia have funded research on modifying tobacco
to produce pharmaceuticals, which might lead to new, high-value crops.
For chemical makers, the new crops offer a tantalizing proposition: Why
build expensive factories when you can simply grow chemicals? By moving a
chicken gene into corn, one company already makes an industrial protein used
in labs around the world. Other companies are betting that gene-altered
plants will cut the costs of making chemicals used in plastics, detergents
and construction materials.
"Think of all the things that could be grown this way," said Anthony
Laos, president of ProdiGene Inc., the Texas company that employs Wiggins
and created the hepatitis B corn, the result of adding a virus gene to the
crop. "Nothing's going to happen overnight, but in 10 years I could see 10%
of the country's corn acres devoted to this."
Known as "biopharming," the process of growing chemicals in modified
plants marks a new direction for biotechnology. Scientists first added genes
to plants in 1983, but so far the technology has mostly been used to make
crops resistant to weedkillers and insects--which cuts the cost of farming.
Biopharming raises many questions familiar from the debate about
genetically engineered foods. The main fears are that adding foreign genes
to plants will prompt allergic reactions in people who eat them, and that
the genes might cause unwanted changes in soil, in insect populations and in
the broader environment. But in transforming plants to grow things that
people do not normally consume, biopharming may raise additional concerns.
"Now we also have to worry about taking vaccines unexpectedly from
these plants," said Joseph Mendelson, legal director for the Center for Food
Safety, a critic of industrial agriculture. "When you talk about something
like a vaccine or chemical that could spread to the environment, I would say
that it raises the concerns to a higher level."
Some groups see genetic manipulation as an unacceptable exploitation of
nature. One radical group, the Earth Liberation Front, even says it set
fires recently at a Seattle genetics research laboratory and an Oregon tree
nursery, doing more than $3 million in damage.
Federal regulators say they are keeping a watchful eye on biopharming,
requiring permits when new crops are grown in open fields. To prevent pollen
from carrying modified genes to new plants, the U.S. Department of
Agriculture requires farmers to separate gene-altered plants from
conventional crops by several hundred feet. The agency sometimes asks
growers to remove the pollen-bearing parts of the plant as well.
To clarify the permit requirements, the Agriculture Department and the
Food and Drug Administration expect to publish a "guidance" document this
summer that spells out what companies must do to grow, transport and contain
biopharmed crops. "They're not going to process them anywhere near your
food," said Kathryn Stein, an FDA official. "The facility would have to be
dedicated to pharmaceuticals.
"Also, we have control over the disposal of all waste materials--what
happens to the residue of the corn, for example--and we will restrict that
so that it does not go into food or feed."
Still, a debacle last year involving one type of genetically engineered
corn gave a black eye to regulators and to biotechnology companies and has
sharpened scrutiny of their work. Sold under the name StarLink, the corn won
approval as an animal feed but not for human consumption, as regulators
wanted more evidence that it would not provoke allergies.
StarLink was grown on less than 0.4% of U.S. corn acreage in 1999. But
thanks largely to poor controls after harvest, it turned up in 430 million
bushels of corn and triggered a recall of more than 300 brands of taco
shells, corn breads and other processed foods. Its creator, Aventis SA of
France, is expected to pay $400 million to farmers in crop buyback programs
and other costs. U.S. taxpayers will spend as much as $20 million to buy
contaminated seed stocks from seed distributors.
The episode prompted some critics to say that corn and other food crops
should never be modified for nonfood purposes. "Promises were made about
containment and segregation, and they weren't kept, and you might say they
could never be kept," said Philip Regal, a University of Minnesota
biologist.
Biopharming firms say comparisons to StarLink are unfair. StarLink and
most other genetically engineered seeds are sold to farmers, who then market
the crops. But ProdiGene does not sell its seeds. It pays farmers for the
use of farmland and for certain growing chores. Laos said: "We basically do
all the harvesting. What's valuable to us needs to be extracted from the
corn, so we never let it get out of our hands."
Biopharming companies also say that, in some ways, their work is not
novel.
The biotechnology industry already makes dozens of drugs by moving
human or other genes into bacteria, yeast or hamster ovary cells, then
encouraging those genes to make proteins. Many proteins can be used as drugs
or as industrial chemicals.
The process, however, requires highly sterile factories, with
fermentation tanks and sophisticated purification processes. By moving the
same genes into plants, companies might save millions of dollars in
construction and operating costs. If a protein drug is a big hit, its
manufacturer would simply plant more of it. And if the market collapses, the
company would just grow less.
One company, Epicyte Pharmaceutical Inc. of San Diego, says it will be
able to make the same quantity of drugs with 200 acres of corn that a
$400-million factory would produce in one year.
ProdiGene makes a similar claim. Since 1996, it has been selling a
version of avidin, a marker protein that helps laboratory workers track what
is going on in chemical reactions.
Avidin has traditionally come from chicken eggs, but ProdiGene
scientists moved the avidin gene out of chickens and into corn. Today, the
company says, a single $2.50 bushel of corn yields the same amount of avidin
that comes from a ton of eggs, which costs about $1,000.
The new wave of crops is aimed at sizable markets. The $2-billion
market for antibody drugs, used to treat cancer, inflammation and other
ailments, is expected to grow to $8 billion by 2004. Epicyte is developing
several "plantibodies," or human antibodies grown in plants.
One scientist, Guy Cardineau of Dow AgroSciences, told a conference
last year that biopharmed chemicals and drugs could be a $200-billion market
within 10 years.
However, the cost of extracting proteins from plants could make some
biopharmed products too costly. And like other drug-makers, biopharming
companies must show the FDA that their products are safe and effective.
Because of the way plants manipulate sugars, a protein made in plants is
sometimes different than the same protein made in mammalian cells.
Plants also may cleave or fold the protein incorrectly, said Dr.
William Haseltine, chief executive of Human Genome Sciences Inc., which has
invested heavily in traditional methods of making gene-derived drugs. "We
believe there are enough risks in the development of new drugs. To add
another one--that is, the method of production--is unwise."
Moreover, it is unclear whether edible vaccines from plants actually
work. The body's digestive system is designed to break down proteins before
they reach the bloodstream. Very few oral vaccines exist today; the oral
polio vaccine is the most common.
But some scientists say that is only a function of cost. "What if you
need 1,000 or 10,000 times the protein to make an oral vaccine work?" asked
John Howard, chief scientific officer at ProdiGene. "The cost would be
prohibitive--except if you grew it in plants."
Hugh Mason, a plant biologist at Cornell University, and colleagues
last year showed that a hepatitis B vaccine grown in potatoes produced an
immune response when fed to mice. Similar tests have been conducted on
humans, but they have not yet been published. "I can say they were
encouraging," Mason said.
At the Nebraska cornfield that Wiggins planted recently, the focus was
not on whether the hepatitis B corn would ever find a market. Instead,
Wiggins and other ProdiGene workers were trying to make sure it would not
find its way to any other field.
After measuring and mapping their test plot, they planted two rows of
conventional corn around the edges. The conventional corn was intended to
catch any pollen that might escape from the gene-altered crop. And next
year, workers said, this plot would be planted with soy, another way to make
sure that stray pollen does not move to new corn plants.
"The only pollen flying around here will be non-transgenic," said Donna
Delaney, a plant geneticist, as she supervised the planting. "Make sure that
people know we're doing our best to keep this stuff out of their food."
** NOTICE: In accordance with Title 17 U.S.C. Section 107, this material is distributed for research and educational purposes only. ** |
|
|
Last Updated on 6/6/01 Email: information@biotech-info.net |
|