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#760 - Year 2002 in Review -- Part 2, Bumpy Road for Biotech, 08-Jan-2003

Unpleasant surprises battered the biotech industry throughout
2002. "Biotech" is short for biotechnology -- the manipulation of
genes to give new traits to bacteria, insects, plants, and

Heavily subsidized by the U.S. government, the biotech industry
has grown rapidly during the past 5 years and new biotech
inventions are announced almost daily. Now whole animals are
being cloned routinely. Many cloned animals die an early death
and others develop painful health problems such as arthritis,
thus raising serious questions about animal cruelty, but some
clones develop normally and even exhibit new traits considered
desirable. Just a few days ago New Zealand researchers announced
that they have cloned cows that produce protein-rich milk,
better-suited for making cheese. "This could be a very cool
thing, especially if you like pizza," said Robert J. Wall, a
scientist at the U.S. Department of Agriculture (USDA), one of
three federal agencies that regulate the biotech industry.[1]

The business of cloning animals has grown very sophisticated very
quickly. During 2002, one company even managed to clone a pig
after it had died. Jon Fisher, owner of Prairie State Semen, Inc.
in Champaign, Ill. had purchased (for $43,000) a champion boar,
which he named 401-K, after his retirement account. When 401-K
died unexpectedly, Fisher salvaged cells from the pig's ear hours
after it had died and sent them off to a company that managed to
produce a new pig nearly identical to 401-K -- the first porcine
resurrection ever recorded. "It was like a bad Woody Allen movie,
the way we were running around here," said Fisher, who expects
meat from 401-K's offspring to sell well in grocery stores
(unlabeled as to source, of course). The U.S. has no laws against
selling meat and milk from cloned animals, but FDA (U.S. Food and
Drug Administration) has asked the cloning industry to
voluntarily withhold its products from market until safety checks
have been completed.[2]

In August the FDA received the safety report it had requested
from the National Academy of Sciences (NAS). Here's how the
WASHINGTON POST summarized the NAS study: "Genetic manipulation
of animals poses serious risks to the environment and potentially
to human health, and federal efforts to manage those risks are
disorganized and probably inadequate, a panel of the National
Academy of Sciences said yesterday."[3]

A month later the WASHINGTON POST reported that the animal
cloning industry is likely to start selling its products to
consumers, unlabeled, as early as 2003, regardless of FDA's
request for a continuing moratorium, because the industry needs
to see a return on its substantial investment in cloning

Regulation of the biotech food industry by the U.S. Food and Drug
Adminstration (FDA) is premised upon a concept called
"substantial equivalence." Crops grown by biotech methods are
allowed onto the market without detailed safety testing because
they are assumed to be "substantially equivalent" to non-biotech
crops. In other words, a tomato given an antifreeze gene from a
flounder is considered by FDA to be "substantially equivalent" to
a normal tomato because it is, after all, still a tomato.

However, an outbreak of serious illness from a genetically
engineered drug, reported in July, 2002, revealed that some
people do not react to genetically engineered proteins as they
would to natural proteins. Their immune systems react to the
engineered protein as if it were a germ and try to destroy it,
damaging the person's body in the process. During 2002, 141
patients taking the biotech drug Eprex had severe immune
reactions to a protein in the drug, with the result that their
bodies stopped making red blood cells. They are now dependent
upon blood transfusions to stay alive. "This has come as a
surprise to us, really," said Professor Huub Schellekens at
Utrecht University in the Netherlands.[4]

The cutting edge of biotech is "biopharming" -- inserting genes
into plants to make them manufacture drugs, vaccines, enzymes,
antibodies, hormones or industrial chemicals such as plastics,
detergents, and adhesives. Most such experiments are being
conducted using corn because it is relatively easy to insert new
genes into corn and because corn excels at making novel proteins
in its seeds.[5,6] A San Diego firm, Epicyte Pharmaceutical,
estimates that it will be able to make the same quantity of drugs
from 200 acres of corn that a $400 million factory could produce
in a year.[7] Gary Cardineau of Dow Agrosciences estimated in
2001 that biopharming would be a $200 billion industry within 10
years.[7] Anthony Laos, president of ProdiGene, Inc., a Texas
biopharming pioneer, predicted that within 10 years, 10% of all
U.S. corn acreage will be devoted to biopharming.[7]

At the time ProdiGene was beginning to "biopharm" experimental
plots of corn (in the open air, not in greenhouses) that had been
altered to produce a vaccine for hepatitis B and was
experimenting with corn that produced a vaccine to prevent
diarrhea in pigs. Simultaneously Epicyte Pharmaceutical in San
Diego and its partner, Dow Chemical, were gearing up to grow
plots of corn engineered to produce a human antibody that fights
the herpes simplex virus.[8]

Epicyte Pharmaceutical also announced in 2001 that it had
discovered a rare class of antibodies that attack human sperm,
which it had then manipulated to create contraceptive corn. "We
have a hothouse filled with corn plants that make anti-sperm
antibodies," Mitch Hein, president of Epicyte, told the LONDON

Corn is known as one of the more promiscuous plants, spreading
its pollen readily to its neighbors. To prevent "biopharmed"
pollen from contaminating conventional cornfields, USDA requires
that experimental plots not be grown closer than 1320 feet (a
quarter-mile) from any other cornfield. The assumption is that
insects, birds, rodents, wind, floods, tornadoes and humans will
never carry biopharmed pollen further than a quarter-mile.

In 2001 biopharmers and government regulators expressed
confidence that they could prevent genetically-altered corn from
contaminating the nation's food supply with biopharmed drugs,
vaccines, contraceptives, industrial plastics, detergents, or
adhesives. "What's valuable to us needs to be extracted from the
corn, so we never let it get out of our hands," said Anthony Laos
of ProdiGene. Kathryn Stein, an FDA official said, "Also, we have
control over the disposal of all waste materials [corn
residues]... and we will restrict that so that it does not go
into food or feed."[7]

Still even the biopharm industry itself didn't seem entirely
convinced that USDA's regulations were adequate to protect the
nation's food supply. October 22, 2002 the Biotechnology Industry
Organization (BIO), a trade association, announced that some of
its members had voluntarily agreed to ban biopharm experiments in
major corn growing states. BIO officials could not say how long
the voluntary ban would last, and not all biopharm firms are
members of BIO. Elected officials in major corn-growing states
like Iowa vowed to fight the ban because, they said, their
farmers desperately need the biopharming business.[9]

The food industry wasn't convinced BIO's voluntary ban would
protect the nation's food supply and continued to lobby Congress
for a new law preventing any biopharm experiments using food
crops. Food processors want biopharmers to use only non-food
crops like tobacco, but biopharmers say this is impractical. "'
We want to ensure that our corn is protected. We are concerned,'
said Mark Dollins, a spokesman for Pepsico, Inc., [a] unit of
Quaker Oats, which has a breakfast-cereal factory in Cedar
Rapids, Iowa, a state that is spending millions of dollars to
attract biopharming firms interested in working on corn plants,
[Iowa's] biggest crop," according to the WALL STREET JOURNAL.[9]

Food processors had been stung two years earlier when genetically
altered Starlink corn -- approved as animal feed but not human
food for fear of allergic reactions -- somehow showed 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 at a
cost exceeding $400 million.[7] "I think we can all agree that
this industry cannot afford Starlink II," said Michael H. Pauly,
director of biotechnology for Epicyte Pharmaceutical, the
inventor of contraceptive corn on the cob.[9]

Starlink II came to pass during November, 2002. The WASHINGTON
POST reported Nov. 13 that government officials had discovered
hundreds of thousands of bushels of soybeans in Nebraska
contaminated with small amounts of biopharmed corn containing a
vaccine to prevent pig diarrhea. The culprit was ProdiGene, the
Texas biopharming pioneer. The following day, USDA officials
announced finding a second ProdiGene lapse -- 155 acres of Iowa
corn contaminated with corn altered to produce ProdiGene's pig
diarrhea vaccine. ProdiGene staff refused to return phone calls
from journalists but issued a press release saying they were
"working to address compliance challenges."[10] None of the
biopharmed corn made it into food products, but it was a close
call with momentous effect.

Stephanie Childs of the Grocery Manufacturers of America (a trade
group) said, "This is an egregious error. They didn't just risk
their crop and their research and their integrity, they risked
the integrity of the U.S. food supply."[11]

As 2002 drew to a close with the biotech industry in turmoil,
U.S. Environmental Protection Agency announced it had levied
fines against two more biopharming firms, in Hawaii, for failure
to abide by the biopharming rules. Dow Agrosciences LLC of
Indianapolis was fined $8,800 for failure to take proper measures
to prevent commercial crops from being contaminated with
experimental biopharmed corn, and Pioneer Hi-Bred, a division of
DuPont, was fined $10,000 for a similar violation. A spokesperson
for Pioneer said the firm had misunderstood the biopharming rules
and promised to try to understand them in the future.[12]

--Peter Montague


[1] Andrew Pollack, "Cloned Cows are Engineered for Faster Cheese
Production," NEW YORK TIMES Jan. 27, 2003, pg. unknown.

[2] Justin Gillis, "Cloned Food Products Near Reality,"
WASHINGTON POST Sept. 16, 2002, pg. A1.

[3] Justin Gillis, "Panel Identifies Gene-Altered Animals' Risk,"
WASHINGTON POST August 21, 2002, pg. A4.

[4] Andrew Pollack, "Rebellious Bodies Dim the Glow of 'Natural'
Biotech Drugs," NEW YORK TIMES July 30, 2002, pg. F5.

[5] Robin McKie, "GM Corn Set to Stop Man Spreading His Seed," LONDON
OBSERVER September 9, 2001, pg. unknown.

[6] Scott Kilman, "Food, Biotech Industries Feud Over Plans for
Bio-Pharming," WALL STREET JOURNAL Nov. 5, 2002, pg. unknown.

[7] Aaron Zitner, "Fields of Gene Factories," LOS ANGELES TIMES
June 4, 2001, pg. unknown.

[8] Paul Elias, Associated Press, "Isle Corn May Help Company
Make Drug for Herpes," HONOLULU STAR-BULLETIN July 11, 2002, pg.

[9] Justin Gillis, "Biotech Industry Adopts Precaution,"
WASHINGTON POST Oct. 22, 2002, pg. E1.

[10] Justin Gillis, "Soybeans Mixed with Altered Corn,"
WASHINGTON POST Nov. 13, 2002, pg. E1.

[11] Elizabeth Weise, "Biotech Corn Mixes With Beans," USA TODAY
Nov. 14, 2002, pg. unknown.

[12] Justin Gillis, "EPA Fines Biotechs for Corn Violations,"
WASHINGTON POST Dec. 13, 2003, pg. E3.