EVERY NOW AND
THEN SCIENCE THROWS US A curve ball, a technology at once staggeringly
useful and breathtakingly dangerous. The most obvious case, of course, is
nuclear power. Down on the farm another revolution is brewing, with
proponents promising a radical new way to deliver drugs that could in
theory solve some of the world's most pressing medical problems. The
potential price -- as always -- is environmental disaster.
An outgrowth of genetic engineering, the technique has
been branded "pharming." Rather than manipulating plants to make a firmer
tomato or a sweeter peach, "pharmers" insert genes that instruct a plant
to manufacture pharmaceutical compounds. In the future they envisage, flu
shots will be replaced by bananas. Prozac, anyone? Try this corn puff.
Pharmers dream that all drugs will ultimately be delivered in snacks.
First out of the pipeline will be vaccines. In August,
industry leader ProdiGene began Phase I clinical trials for a vaccine
against traveler's diarrhea. Resulting from a dismal species of E. coli,
the condition is also a prime cause of infant mortality in many poorer
nations. Instead of pursuing the regular path of cell-culturing and
purification, Texas-based ProdiGene hopes to deliver a vaccine in a simple
kernel of corn.
To understand what is at stake here, consider the case
of hepatitis B. Worldwide, that virus kills more than 900,000 people a
year, many of them in China, where the disease is at almost epidemic
levels. A dose of hep-B vaccine costs around 50 cents, yet even that -- in
quantity -- is beyond the budgets of many developing countries. Besides
the cost of the drug itself, vaccination is hampered by the additional
expense of needles and by lack of refrigeration. Vaccines produced the
traditional way cost thousands of dollars a gram, but corn can be grown
for 5 cents a pound. Hoping to tap into the huge hepatitis market,
ProdiGene is currently conducting field trials on a strain of transgenic
corn that has been spliced with hep-B antigens.
ProdiGene even has its eye on AIDS. Two years ago the
company received a $300,000 grant from the National Institutes of Health
to research the possibility of a plant-based vaccine against the HIV
virus. As a test of the concept, company scientists are beginning with the
primate version, simian immunodeficiency virus, by splicing into corn the
SIV genes responsible for producing a protein called GT120, which is known
to trigger antibodies against the deadly invader. The NIH itself will
conduct the clinical trials, and if all goes well it will move on from
there to a human version.
In theory, just about any drug could be engineered in a
kernel of corn or a grain of rice. Earlier this year ProdiGene announced
it was scaling up transgenic production of aprotinin, a protease inhibitor
used in cardiac surgery. Traditionally extracted from bovine lungs,
aprotinin reduces the need for blood transfusions in patients undergoing
bypass surgery. Once the initial splicing is done, such transgenic crops
can be grown anywhere, from Nebraska to Nigeria.
Pharmers are also looking to actual farms. Every year
millions of animals have to be vaccinated at enormous expense to their
owners and considerable stress to the creatures. Transmissible
gastroenteritis virus (TGEV), for example, is a highly contagious disease
that kills infant pigs. Clinical trials by ProdiGene have shown that in
principle plant-based vaccines can be effective against this pathogen. As
with many biotech products, the development of transgenic vaccines will be
driven initially by the demands of animal husbandry.
To protect our health, we have fluoride in our water and
iodine in our salt; why not deliver codeine in corn flakes, Wellbutrin in
Ho Ho's? The problem, says Norman Ellstrand, a plant geneticist at UC
Riverside, is that transgenic crops are incredibly difficult to isolate.
Scientists now know that genes are routinely passed among plant species,
and "gene flow" from genetically manufactured (GM) organisms to wild
varieties has been documented all over the world. That's bad enough when a
gene involved conveys herbicide resistance, but when you're talking about
genes for proteins and hormones, the potential for disaster is enormous --
both for human health and the environment. "We need to be assured of zero
tolerance," Ellstrand says, but that's almost impossible to guarantee.
Genes aren't the only things that are hard to contain.
Remember the Starlink debacle, when GM maize intended for animal feed
found its way into taco shells? Imagine if the modified grain had
contained a drug -- any drug. With vast amounts of grain being shipped
around the world, Ellstrand believes it won't be possible to prevent such
mix-ups. Sooner or later, innocent folk chowing down on corn chips or
sesame buns are going to find their bloodstreams coursing with aprotinin
or swine vaccine or God knows what else. According to Jane Rissler of the
Union of Concerned Scientists, "The food industry is apoplectic about the
possibility of this stuff getting into the food supply." Rissler and
Ellstrand argue that pharming should be strictly limited to nonfood crops
-- to, say, tobacco or castor beans.
IN THE DEVELOPED WORLD, WHERE DRUGS CAN be delivered in
so many other ways, it seems hard to justify the risk of pharming -- as
with nuclear power, we really do have alternatives. But in the developing
world, millions of people die each year from preventable diseases for lack
of very basic drugs. That at least is the argument pushed by the biotech
industry. Yet just as people are challenging the GM solution to Africa's
food crisis, so, Rissler says, the Third World's health problems are not
going to be solved by cutting-edge technology.
The idea of helping the Third World with transgenic
vaccines is little more than "a ruse," Rissler believes. "It's selling
biotechnology on the back of the poor," by attempting to make it palatable
to well-off folks like us. Rissler points out that to be medically
effective drugs have to be delivered in the right dose. How would people
know how much they were supposed to eat? A whole banana, half a banana?
Who's to say? More critical, how could you be sure that people wouldn't
overdose? How would you even know you were eating the right variety? After
all, a genetically modified banana looks the same as a regular one.
Rissler is skeptical of the medical miracle promised by companies like
ProdiGene and suspects that a lot of the blue-sky ideas being bandied
about will "never see the light of day as commercial products."
Behind the hype about cheap drugs, Rissler and Ellstrand
note that the pharming industry is quietly pursuing a much bigger goal --
engineering into plants genes that encode for all manner of industrially
useful compounds, from enzymes to solvents. Since these don't qualify as
drugs, they are not regulated by the Federal Drug Administration, and very
little information is publicly available about what is going on here.
Earlier this year the U.S. Department of Agriculture updated its
guidelines for industrial pharming, but many scientists believe these are
grossly inadequate.
USDA spokesman Jim Rogers acknowledges that "Nobody's
going to know all the possible risks. But, he says, "We mitigate these
risks to what we feel is appropriate." In the department's view, "There
are adequate safety provisions in place." Not according to Rissler, who
opines that "The USDA's oversight is way too lax." Given the enormous
potential dangers, Rissler insists there ought to be external scientific
oversight as well. What most appalls Ellstrand, who sat on a National
Academy of Sciences committee that reviewed the regulations for GM crops,
is that companies do not have to disclose what genes they are adding, or
even what organisms the genes derive from -- that's "confidential business
information."
Quietly and stealthily, our fields are being turned into
industrial factories. This is potentially the most dangerous technology
since nuclear power, yet we have no way of finding out what is being done.
It's yet another way in which for the present administration, Business
comes first.