THE BIOPHARMACEUTICAL HARVEST
Carmelo Ruiz-Marrero
Just when the worldwide controversy over genetically modified (GM) foods and crops is growing larger and more heated, the biotechnology industry is getting ready to introduce a whole new class of GM plants whose very properties promise to make the biotech issue even more complicated and thorny than it already is.
These new biotech plants, called biopharmaceutical or pharm crops, produce pharmaceutical and industrial chemicals in their tissues. These plants, which include corn, soy, rice and tobacco, have been engineered to make products like growth hormones, blood clotting agents, vaccines-both for humans and farm animals-, human antibodies, industrial enzymes, contraceptives and even abortion-inducing drugs for morning-after pills.
"Think of harvesting enough anti-arthritic globulin for the whole world from less than 50 acres of corn", wrote physician William O. Robertson, a pharm crop enthusiast, in an op-ed in the Seattle Post-Intelligencer. "Think of finding the protein that healthy people use to ward off arthritis or breast cancer and producing it in affordable quantities in rice or tobacco."
By the end of this decade 10% of all corn grown in the US will be biopharmaceutical, says Anthony Laos, CEO of Prodigene, a Texas-based company that is the leader in this new field. Guy Cardineau, a scientist at Dow Agrosciences, predicts that biopharmaceutical products could become a $200 billion market by the beginning of next decade.
But some environmentalists and scientists are wary of this new biotech harvest, and they are unsettled by the fact that the US Agriculture Department (USDA) has permitted the companies involved to maintain specific information about these experiments sccret as "confidential business information". They ask, how are pharm crops going to be segregated from non-pharm crops? How do we keep them from pollinating other fields? How to prevent inventory errors that might accidentally send them into the food supply? They fear the result could be a biological Chernobyl with unimaginable consequences for human health and the environment.
"How will crops that are engineered to produce industrial chemicals or drugs affect soil micro-organisms or beneficial insects?" asks the Action Group on Erosion, Technology and Concentration (ETC Group), a Canada-based think-tank. "What if biopharmaceutical crops end up in animal feed? Will pharmaceutical proteins be altered in unforeseen ways? Could they cause allergies?"
"Most noteworthy are problems of cross-pollination, and unknown deleterious effects on insects, soil microbes and other native organisms," according to biologist Brian Tokar, professor at the Institute for Social Ecology. "Further, we may soon see biologically active enzymes and pharmaceuticals, only found in nature in minute quantities -- and usually biochemically sequestered in very specialized regions of living tissues and cells-- secreted by plant tissues on a massive commercial scale."
"The consequences may be even more difficult to detect and measure than those associated with more familiar GM crop varieties, and could escalate to the point where those now-familiar problems would begin to pale by comparison", Tokar warned.
"Just one mistake by a biotech company and we'll be eating other people's prescription drugs in our corn flakes", said Larry Bohlen, director of health and environment programs at Friends of the Earth.
CAN PHARM CROPS EVER BE CONTAINED?
Mistakes have happened already. In the Fall of 2002, 500,000 bushels of soybeans in the Aurora Farm Co-op in Nebraska were contaminated with biopharmaceutical corn. How did that happen? One of the co-op's members had planted an experimental test crop of biopharmaceutical corn the previous year, and in the following year planted soybeans for human consumption in the same field.
During a routine on-site inspection, USDA personnel found the pharm crop from the previous year growing among the soy plants. By the time the discovery was made, the farmer's contaminated soy was already in the co-op, mixed with other farmers' soy. Fortunately, the tainted product was stopped before ending up on our dinner tables. The pharm crop's maker, Prodigene, was fined $500,000. In spite of this near disaster, federal authorities still permit the company to plant biopharmaceutical test plots, and have also allowed it to keep the exact nature of the corn involved in the Nebraska incident confidential.
Activists were outraged by what they perceived as the kid gloves treatment the company got. "This is the Three Mile Island of biotech", said Mark Ritchie, president of the Institute for Agriculture and Trade Policy, commenting on what has come to be known as the Prodigene Affair.
After the Prodigene Affair, two industry organizations that had previously supported biotechnology in an uncritical way began having second thoughts. Spokespersons of the Grocery Manufacturers Association expressed concern about pharm crops adulterating the food supply, and National Food Processors Association president John Cady called for stringent and mandatory regulations to protect the food supply from biopharmaceuticals. But the Biotechnology Industry Organization and the pro-biotech American Farm Bureau Federation continued lobbying in Washington for more support and less regulation of biopharming.
Pollution of the American food supply by biotech products has already happened. In the Fall of 2000, hundreds of supermarket products containing corn were found to be contaminated with Starlink, a GM corn variety deemed unfit for human consumption by the Food and Drug Administration. Even though it had been planted on only 0.04% of US corn fields and meant to be used only as cattle feed, Starlink ended up tainting 430 million bushels of corn and to this day traces of it keep showing up on US exports.
Even more serious genetic contamination is taking place in Mexico, where GM corn has been found growing in rural areas in nine states, agressively proliferating and cross-breeding with local varieties, even though the Mexican government had banned biotech crops in 1998. This discovery is alarming, since that country is the birthplace of corn and its center of diversity, and the long term consequences of this contamination are uncertain.
Some in Mexico are worried that biopharmaceutical corn could pollute their corn fields. Silvia Ribeiro, who heads the ETC Group's office in Mexico City, has noted with concern that the California-based Epicyte corporation boasts a spermicidal corn for use as a contraceptive. "The potential of spermicidal corn as a biological weapon is very high", she warned, and reminisced about the use of forced sterilizations against indigenous peoples.
WORLDWIDE
Where in the world are biopharm crops being planted? All over the world.
Molecularfarming.com, an industry web site, is soliciting farmers all over the world willing to rent out their lands for pharm crop experiments. It claims to have brokered deals with farmers in countries like Brazil, Ireland, Australia, Greece, Zimbabwe, Panama and many more.
Beth Burrows, president of the Edmonds Institute, a public interest group that works on biosafety issues, was aghast when she found this web site.
"With bioengineered piglets going unapproved to market, with experimental crops contaminating 150 acres of corn and half a million bushels of soybeans, with an engineered corn unapproved for human consumption turning up all over the world, at a time when the environmental and human health problems posed by the so-called 'pharm crops' desperately need the clear scientific light of day, people are brokering contract pharming deals on the web," cautioned Burrows.
"This is shocking indeed", commented Devinder Sharma, award-winning journalist and food systems analyst based in India, after seeing the Molecular Farming web site. "This is part of the global design to translocate the dirty industry to the Third World. First, it was the translocation of toxic and hazardous waste recycling to developing countries (mainly South Asia and Africa)… Now, it is the turn of bio-pharma crops. Even in the United States, there are tremendous problems with bio-pharma crops. So what do you do? Translocate this dirty industry to countries of South Asia."
ASSURANCES
But the defenders of biopharming keep assuring us that it's perfectly safe. Dr. Allan S. Felsot, an environmental toxicologist at Washington State University, says that biopharming "is not even a new concept considering that humans have been using medicinal plants for ages. These non-biotechnology-derived medicinal plants must be grown and harvested and extracted in a manner that ensures the integrity and safety of the medicine."
Felsot claims that there is nothing novel about proteins being manufactured in GM plants. "The therapeutic proteins are the same as those already in our body. Most of the proteins have already been produced as medicines using cell fermentation. They’re well characterized and have been through safety assessments and often human clinical trials. The manufacturing process is the real novelty, but it will be regulated stringently as if the protein was being manufactured in a factory."
"The possibilities are mind-boggling; the opportunities can't be fully appreciated, and the risks seem minuscule compared with some of the risks we've had to cope with in medicine throughout the years", says Dr. William Robertson in the op-ed quoted earlier. "The self-imposed and federally mandated precautions amount to safety carried out to the 19th decimal place. None of the players is ready to take the slightest risk for granted".
THE CHILLING ENDNOTE
"Exactly what would make the USDA take seriously the fact that millions of people were nearly fed experimental drugs and chemicals?", asks Brandon Keim, of the Council for Responsible Genetics, referring to the Prodigene affair. "A few spectacular deaths, perhaps, or a steady increase in debilitating disorders that is only noticed decades later, when it is too late?"
Meanwhile, pharm crops await commercial approval by the government.
SOURCES:
Philip Cohen. "Drug genes could enter food chain". New Scientist, 6 July 2002. http://www.organicconsumers.org/gefood/pharmaceuticals0702.cfm
Council for Responsible Genetics. Official Statement on Biopharmaceutical Crops. http://www.gene-watch.org/programs/biosafety/biopharming-statement.html
Environment News Srvice. "Secret U.S. Biopharms Growing Experimental Drugs" http://ens-news.com/ens/jul2002/2002-07-16-05.asp
Genetically Engineered Food Alert http://www.gefoodalert.org
Genetically Engineered Food Alert. New Alarming Report on Hazards of Biopharming http://www.OrganicConsumers.org/gefood/Biopharming0702.cfm
Brandon Keim. "Biopharm Roulette". Alternet, 27 November 2002. http://www.alternet.org/story.html?StoryID=14647
John Nichols. "The Three Mile Island of biotech". The Nation, 30 December 2002.
http://www.mindfully.org/GE/GE4/Biotech-Three-Mile-Island30dec02.htm
Prodigene http://www.prodigene.com/
Silvia Ribeiro. "Maíz contra humanos". La Jornada, 25 January 2002. http://www.biodiversidadla.org/article/view/466
Silvia Ribeiro. "Granjas secretas y drogas transgénicas" La Jornada. 11 August 2002 http://www.jornada.unam.mx/2002/ago02/020811/016a1pol.php?origen=opinion.html
Mike Toner. "GE Pharming Generating Controversy". Atlanta Journal and Constitution, 19 May 2002. http://www.organicconsumers.org/patent/futurestuff052002.cfm
Carmelo Ruiz-Marrero
Just when the worldwide controversy over genetically modified (GM) foods and crops is growing larger and more heated, the biotechnology industry is getting ready to introduce a whole new class of GM plants whose very properties promise to make the biotech issue even more complicated and thorny than it already is.
These new biotech plants, called biopharmaceutical or pharm crops, produce pharmaceutical and industrial chemicals in their tissues. These plants, which include corn, soy, rice and tobacco, have been engineered to make products like growth hormones, blood clotting agents, vaccines-both for humans and farm animals-, human antibodies, industrial enzymes, contraceptives and even abortion-inducing drugs for morning-after pills.
"Think of harvesting enough anti-arthritic globulin for the whole world from less than 50 acres of corn", wrote physician William O. Robertson, a pharm crop enthusiast, in an op-ed in the Seattle Post-Intelligencer. "Think of finding the protein that healthy people use to ward off arthritis or breast cancer and producing it in affordable quantities in rice or tobacco."
By the end of this decade 10% of all corn grown in the US will be biopharmaceutical, says Anthony Laos, CEO of Prodigene, a Texas-based company that is the leader in this new field. Guy Cardineau, a scientist at Dow Agrosciences, predicts that biopharmaceutical products could become a $200 billion market by the beginning of next decade.
But some environmentalists and scientists are wary of this new biotech harvest, and they are unsettled by the fact that the US Agriculture Department (USDA) has permitted the companies involved to maintain specific information about these experiments sccret as "confidential business information". They ask, how are pharm crops going to be segregated from non-pharm crops? How do we keep them from pollinating other fields? How to prevent inventory errors that might accidentally send them into the food supply? They fear the result could be a biological Chernobyl with unimaginable consequences for human health and the environment.
"How will crops that are engineered to produce industrial chemicals or drugs affect soil micro-organisms or beneficial insects?" asks the Action Group on Erosion, Technology and Concentration (ETC Group), a Canada-based think-tank. "What if biopharmaceutical crops end up in animal feed? Will pharmaceutical proteins be altered in unforeseen ways? Could they cause allergies?"
"Most noteworthy are problems of cross-pollination, and unknown deleterious effects on insects, soil microbes and other native organisms," according to biologist Brian Tokar, professor at the Institute for Social Ecology. "Further, we may soon see biologically active enzymes and pharmaceuticals, only found in nature in minute quantities -- and usually biochemically sequestered in very specialized regions of living tissues and cells-- secreted by plant tissues on a massive commercial scale."
"The consequences may be even more difficult to detect and measure than those associated with more familiar GM crop varieties, and could escalate to the point where those now-familiar problems would begin to pale by comparison", Tokar warned.
"Just one mistake by a biotech company and we'll be eating other people's prescription drugs in our corn flakes", said Larry Bohlen, director of health and environment programs at Friends of the Earth.
CAN PHARM CROPS EVER BE CONTAINED?
Mistakes have happened already. In the Fall of 2002, 500,000 bushels of soybeans in the Aurora Farm Co-op in Nebraska were contaminated with biopharmaceutical corn. How did that happen? One of the co-op's members had planted an experimental test crop of biopharmaceutical corn the previous year, and in the following year planted soybeans for human consumption in the same field.
During a routine on-site inspection, USDA personnel found the pharm crop from the previous year growing among the soy plants. By the time the discovery was made, the farmer's contaminated soy was already in the co-op, mixed with other farmers' soy. Fortunately, the tainted product was stopped before ending up on our dinner tables. The pharm crop's maker, Prodigene, was fined $500,000. In spite of this near disaster, federal authorities still permit the company to plant biopharmaceutical test plots, and have also allowed it to keep the exact nature of the corn involved in the Nebraska incident confidential.
Activists were outraged by what they perceived as the kid gloves treatment the company got. "This is the Three Mile Island of biotech", said Mark Ritchie, president of the Institute for Agriculture and Trade Policy, commenting on what has come to be known as the Prodigene Affair.
After the Prodigene Affair, two industry organizations that had previously supported biotechnology in an uncritical way began having second thoughts. Spokespersons of the Grocery Manufacturers Association expressed concern about pharm crops adulterating the food supply, and National Food Processors Association president John Cady called for stringent and mandatory regulations to protect the food supply from biopharmaceuticals. But the Biotechnology Industry Organization and the pro-biotech American Farm Bureau Federation continued lobbying in Washington for more support and less regulation of biopharming.
Pollution of the American food supply by biotech products has already happened. In the Fall of 2000, hundreds of supermarket products containing corn were found to be contaminated with Starlink, a GM corn variety deemed unfit for human consumption by the Food and Drug Administration. Even though it had been planted on only 0.04% of US corn fields and meant to be used only as cattle feed, Starlink ended up tainting 430 million bushels of corn and to this day traces of it keep showing up on US exports.
Even more serious genetic contamination is taking place in Mexico, where GM corn has been found growing in rural areas in nine states, agressively proliferating and cross-breeding with local varieties, even though the Mexican government had banned biotech crops in 1998. This discovery is alarming, since that country is the birthplace of corn and its center of diversity, and the long term consequences of this contamination are uncertain.
Some in Mexico are worried that biopharmaceutical corn could pollute their corn fields. Silvia Ribeiro, who heads the ETC Group's office in Mexico City, has noted with concern that the California-based Epicyte corporation boasts a spermicidal corn for use as a contraceptive. "The potential of spermicidal corn as a biological weapon is very high", she warned, and reminisced about the use of forced sterilizations against indigenous peoples.
WORLDWIDE
Where in the world are biopharm crops being planted? All over the world.
Molecularfarming.com, an industry web site, is soliciting farmers all over the world willing to rent out their lands for pharm crop experiments. It claims to have brokered deals with farmers in countries like Brazil, Ireland, Australia, Greece, Zimbabwe, Panama and many more.
Beth Burrows, president of the Edmonds Institute, a public interest group that works on biosafety issues, was aghast when she found this web site.
"With bioengineered piglets going unapproved to market, with experimental crops contaminating 150 acres of corn and half a million bushels of soybeans, with an engineered corn unapproved for human consumption turning up all over the world, at a time when the environmental and human health problems posed by the so-called 'pharm crops' desperately need the clear scientific light of day, people are brokering contract pharming deals on the web," cautioned Burrows.
"This is shocking indeed", commented Devinder Sharma, award-winning journalist and food systems analyst based in India, after seeing the Molecular Farming web site. "This is part of the global design to translocate the dirty industry to the Third World. First, it was the translocation of toxic and hazardous waste recycling to developing countries (mainly South Asia and Africa)… Now, it is the turn of bio-pharma crops. Even in the United States, there are tremendous problems with bio-pharma crops. So what do you do? Translocate this dirty industry to countries of South Asia."
ASSURANCES
But the defenders of biopharming keep assuring us that it's perfectly safe. Dr. Allan S. Felsot, an environmental toxicologist at Washington State University, says that biopharming "is not even a new concept considering that humans have been using medicinal plants for ages. These non-biotechnology-derived medicinal plants must be grown and harvested and extracted in a manner that ensures the integrity and safety of the medicine."
Felsot claims that there is nothing novel about proteins being manufactured in GM plants. "The therapeutic proteins are the same as those already in our body. Most of the proteins have already been produced as medicines using cell fermentation. They’re well characterized and have been through safety assessments and often human clinical trials. The manufacturing process is the real novelty, but it will be regulated stringently as if the protein was being manufactured in a factory."
"The possibilities are mind-boggling; the opportunities can't be fully appreciated, and the risks seem minuscule compared with some of the risks we've had to cope with in medicine throughout the years", says Dr. William Robertson in the op-ed quoted earlier. "The self-imposed and federally mandated precautions amount to safety carried out to the 19th decimal place. None of the players is ready to take the slightest risk for granted".
THE CHILLING ENDNOTE
"Exactly what would make the USDA take seriously the fact that millions of people were nearly fed experimental drugs and chemicals?", asks Brandon Keim, of the Council for Responsible Genetics, referring to the Prodigene affair. "A few spectacular deaths, perhaps, or a steady increase in debilitating disorders that is only noticed decades later, when it is too late?"
Meanwhile, pharm crops await commercial approval by the government.
SOURCES:
Philip Cohen. "Drug genes could enter food chain". New Scientist, 6 July 2002. http://www.organicconsumers.org/gefood/pharmaceuticals0702.cfm
Council for Responsible Genetics. Official Statement on Biopharmaceutical Crops. http://www.gene-watch.org/programs/biosafety/biopharming-statement.html
Environment News Srvice. "Secret U.S. Biopharms Growing Experimental Drugs" http://ens-news.com/ens/jul2002/2002-07-16-05.asp
Genetically Engineered Food Alert http://www.gefoodalert.org
Genetically Engineered Food Alert. New Alarming Report on Hazards of Biopharming http://www.OrganicConsumers.org/gefood/Biopharming0702.cfm
Brandon Keim. "Biopharm Roulette". Alternet, 27 November 2002. http://www.alternet.org/story.html?StoryID=14647
John Nichols. "The Three Mile Island of biotech". The Nation, 30 December 2002.
http://www.mindfully.org/GE/GE4/Biotech-Three-Mile-Island30dec02.htm
Prodigene http://www.prodigene.com/
Silvia Ribeiro. "Maíz contra humanos". La Jornada, 25 January 2002. http://www.biodiversidadla.org/article/view/466
Silvia Ribeiro. "Granjas secretas y drogas transgénicas" La Jornada. 11 August 2002 http://www.jornada.unam.mx/2002/ago02/020811/016a1pol.php?origen=opinion.html
Mike Toner. "GE Pharming Generating Controversy". Atlanta Journal and Constitution, 19 May 2002. http://www.organicconsumers.org/patent/futurestuff052002.cfm
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