Bumpy Road for Biotech

January 30, 2003

Environmental Research Foundation
P.O. Box 160, New Brunswick, N. J. 08903
Fax (732) 791-4603; E-mail: erf@rachel.org

Year 2002 in Review–Part 2

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 animals.

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 withold 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 technology. [2]

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 Pharma-ceutical in San Diego and its partner, Dow Chemical, were gearing up to growplots 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 OBSERVER.

Corn is known as one of the more promiscuous plants, spreading its pollen readily to its neighbors. To prevent "biopharmed" pollen from contaminating conventional corn fields, USDA requires that experimental plots not be grown closer than 1320 feet (a quarter-mile) from any other corn field. 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.

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