[Agri Alert-118] Pharma Crops - Medicine or Poison?

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Agri-Alert 118 09.04.07 Let us grow foOd, not money Let us work towards a Green

Orissa. Contents:1 Q & A on Pharma Crops. 2. "Pharma Crops" threaten food safety.Comments: In our last issue we talked about the health hazards of GM crop. Ironically the same technology is being used to develop medicines and vaccines for use on humans and animals. As the following articles point out there has been no serious attempt to evaluate the risks involved. Ordinarily food supplies all our needs. Hippocrates, the father of modern medicine, declared this very emphatically when he said, "Let food be thy medicine". But chemicals were used instead and today we suffer from poisoned bodies and minds. Food itself has become a poison thanks to chemical fertilisers and pesticides. Now we are going a step further and leaping into the unknown. If we cultivate GM crop with medicinal properties we no longer give medicines to those who need them but we medicate the entire population. A highly questionable act. Not only that, through contamination, the medicinal ("poisonous"

would be the more appropriate word) properties would jump into other plant species also. What about existing medicinal plants, those which we are turning to to save ourselves from the relentless chemical onslaught? Would not they too get contaminated? Medical "science" seems hell bent on systematically destroying all our routes to survival as a species. Has there been any thought towards steps to be taken when things go wrong? What protocols are in place in case of such an eventuality? Or will things move when millions start dying? Likely not as we see government machinery preferring to turn a blind eye towards the spate of farmers suicides. Human life is no longer important. It is an "input" for experimentation and little else. "Clinical detachment" has reached its nadir. There is another aspect to it. Land available for ordinary beneficial food gets further depleted. We already have non food cash crops and industries eating into agricultural land. This is thus another blow. We would request you once again to share these articles with your friends, colleagues and groups. Please share your views and experiences with us at livingfarms(at)gmail.com. Q & A on pharmaceutical crops Q: What is a "pharm" crop? Genetic engineering (GE) corporations are creating crops that produce proteins that are

pharmaceuticals, vaccines, industrial enzymes or reagents for biochemical laboratories. Genetically engineered (GE) "pharm" crops are mostly grown in open fields, then after harvest the novel protein is purified for use. Most pharm crops are in pre-commercial field trials, but at least two proteins used in biochemical and diagnostic procedures are already being grown in corn for commercial use – avidin and beta-glucuronidase. Other proteins from pharm crops are already in clinical trials. Open field trials of pharmaceutical crops have been taking place every growing season in the US since 1992. If these altered crops were released into the environment theycould never be recalled and could enter the food chain. None of the companies have a commercial permit for the cultivation of these crops. In the case of avidin and beta-glucuronidase, the companies are selling the chemical in commercial channels, but hiding their actions behind a "research" permit

provided by the USDA. With this type of permit, the chemicals and field locations can be kept secret. Q: What kind of products are companies developing in gene altered plants? About 20 companies worldwide are developing plants for the production of pharmaceutical or industrial proteins using rice, wheat, corn, barley, tomatoes and other plants. Companies have already conducted open field trials of plants that produce Hepatitis B vaccine, human antibodies against herpes and other diseases, and human blood proteins. One company is developing an animal drug in corn, and suggests that the corn would be grown only for feed. Field trials have taken place at least in the US, France, and Canada. Q: What

is Greenpeace protesting today? A California company called Applied Phytologics, Inc. (API) is conducting field experiments of genetically engineered rice that is altered to produce human proteins for use as drugs or other non-food uses. We know there are drugs in these rice fields because of the type of permits issued by the USDA for these particular field trials. These "test fields" mean release of genetically engineered organisms into the environment – in this particular case the GE fields are even located close to a conventional rice fields. The GE varieties are likely to contaminate also their wild relatives as well as their whole environment. This environmental risk is unnecessary as these chemicals can be produced in other ways. Q: What drugs is this rice actually

producing? According to the information submitted by the company to the USDA, there are nine different compounds being produced in the Applied Phytologics fields. Eight of the nine compounds come from humans, that is, there are eight different human genes engineered into the rice plants. API is producing human lysozyme, human lactoferrin, human alpha-1-antitrypsin, and an unidentified human trefoil factor, among other compounds that the company claims as secret "confidential business information." Human lactoferrin and human lysozyme are commonly found in breast milk, as well as in human bile and tears. They both possess antimicrobial properties, that is, they have been shown to kill certain bacteria. Lactoferrin binds to iron and kills bacterial cells by depriving them of this essential mineral. It has also been shown to promote cell growth and has

immune-modulating effects. Lysozyme breaks apart bacterial cells and is a common reagent in molecular biology laboratories. Álpha-1-antitrypsin is used to treat symptoms of cystic fibrosis, emphysema, and liver disease. All these compounds can be produced by other less risky means. Q: Why is Applied Phytologics producing these drugs in a plant? All the companies experimenting with pharmaceutical and industrial enzyme crops (see attached table) claim that the method has lower costs than production within a pharmaceutical facility. One company says that just 200 acres of corn would produce the same amount of drugs that would otherwise require building a $400-million factory. Moreover, by making the compounds in crop plants, rather than non-food plants, they can take advantage of all the cultivation,

harvest, and processing machinery already designed. Rice or corn fields producing pharmaceuticals provide a high yield of the material that can be harvested and processed on a very large scale in regular food crop facilities before being sent to the pharmaceutical factory for further purification. This means, of course, that there is a great risk for pharmaceutical crops to mix with crops destined for human or animal food. Applied Phytologics has formed partnerships with two different companies that have malting capabilities – Coors Brewing Company (US) and Maltagen Forschung GmbH (Germany) – as the pharm rice or barley needs to be malted before the proteins can be isolated. Beer-making facilities could also become contaminated. Q: Could this rice contaminate other plants? According to Norman Ellstrand,

professor of botany at the University of California at Riverside, cultivated rice can easily transfer its genes to wild and weedy relatives, such as red rice, a common weed in California rice fields. If pharm rice pollinates nearby food rice, or red rice, the pharmaceutical protein would be produced in the resulting rice grains, thereby contaminating human and/or animal food sources. Scientists do not know exactly how far rice pollen can travel. Q: How is this crop dangerous to me? There have been no peer reviewed scientific studies published on the safety of pharmaceuticalproducing rice. No one knows whether this rice is safe to eat. We do know from experience that companies have failed to segregate GE from non-GE crops, even when directed by the government to ensure segregation, such as in last year's

StarLink fiasco. Because there are numerous ways that rice for human consumption could become contaminated with pharm rice, use of rice or any other food crop for pharmaceutical production should be stopped in open fields. Q: Does this crop pose an environmental risk? Yes. There are many other organisms in the environment that consume rice or rice plants. The most well-known are the millions of ducks that visit California's Central Valley every winter and eat the rice seed remaining in the fields. Q. Is Greenpeace opposed to all pharmaceutical crops? We are opposed to the introduction into the environment of all engineered crops. We

are not opposed to contained greenhouse cultivation. Q: What does Greenpeace want? Crops engineered to produce pharmaceutical or industrial proteins should not be grown in open fields. Greenpeace is calling for a ban on the release of genetically engineered crops, since these plants will irreversibly alter the natural environment, with potentially devastating consequences for food production and biodiversity. 'Pharma Crops' Threaten Food Safety

by Stephen Leahy BROOKLIN, Canada - Medicine and farming are merging as genetically engineered (GE) maize and soy crops promise cheap drugs, but they also threaten to contaminate food and the environment, warn activists and experts. The United States has planted very small amounts of these experimental 'pharma crops' since the early 1990s, including about 18 hectacre in 2004, according to the U.S. Department of Agriculture. Although full-scale production is a few years away, a new report is warning that when it begins, the U.S. food supply will be contaminated sooner or later. "It is sobering that drugs and industrial chemicals could have so many routes to the food supply," said David Andow, the report's editor and a professor at the University of Minnesota. The Union of Concerned Scientists (UCS), an environmental non-governmental organization (NGO) that asked six independent scientists to prepare the report, is calling for an immediate ban on the field production of food or feed crops engineered to produce pharmaceuticals and industrial chemicals. "Biopharming"

is a subset of biotechnology that turns ordinary plants and animals into protein production factories through genetic engineering. Until recently nearly all drugs were manufactured via synthetic chemical processes. But in the last 20 years the science of biotechnology has led to a new class of drugs called "bio-pharmaceuticals" -- therapeutic proteins produced by living cells through microbial fermentation or mammalian cell culture. The most successful of these has been GE (also known as GM or genetically modified) insulin, which is used by millions of diabetics around the world. In the early 1980s a human gene for insulin production was stitched into the DNA (the building blocks of the cells of all living things) of the bacteria E coli. With a much lower manufacturing cost, this process completely overtook the traditional

source of insulin -- the pancreas of cows and pigs. Thousands of diabetics have experienced bad reactions and many have died as a result of this new GE insulin, called synthetic or "human" insulin, according to the Society for Diabetic Rights. Despite this, more than 100 bio-pharmaceutical products or "biologics" -- serums, antitoxins, vaccines and biological therapeutics ¡- have been approved for use in the United States. Worldwide, another 500 are in clinical trials. These are not always new drugs; many simply replace existing products, like insulin. The demand for these biologics is

skyrocketing, with the market expected to top 56 billion U.S. dollars in 2006 in the United States alone. However, GE bacterial fermentation systems cost hundreds of millions of dollars to build, require perfect growing conditions and are easily contaminated by other bacteria. By comparison, plants are bargain-basement "bio factories," costing potentially just 10 percent of the fermentation manufacturing process. GE plants offer the additional advantage of being free of bacteria and viruses that could infect people. Industry reports indicate roughly 300 companies, including some large pharmaceutical and agriculture-biotech corporations are involved in developing these plant factories. One of

the most ambitious is a European-South African alliance to produce plant-derived drugs for the developing world, including antibodies to prevent HI, the virus that causes AIDS. Launched in July with 12 million euros in funding from the European Union, the Pharma-Planta Consortium and South Africa's Council for Science and Industrial Research, backers hope the project's first product will be a cream containing HIV antibodies to prevent transmission of the virus during sex. Those antibodies are being engineered into maize in a highly experimental effort in South Africa. Other antibodies for use in a tuberculosis vaccine are also being inserted into maize. Field trials of the GE crops are two-three years away, while clinical

trials on humans are projected within five years. But cautionary voices warn that the undeniable potential benefits of biopharming to produce life saving, low-cost drugs for the developing world have to be weighed against the risks of the new technology. Among the first countries dealing with these risks is the United States, but its regulators seem to be in denial, according to Jane Rissler, a UCS scientist. The U.S. food and drug safety system is considered among the best in the world, and Rissler has no doubt the drugs derived from biopharming will undergo extensive safety testing. However, those responsible

for food safety at the U.S. Department of Agriculture (USDA) have not put strict regulations into place to prevent pharmalogically-active proteins from slipping into America's foods, she said. And that is despite the fact it almost happened two years ago, when experimental maize plants containing a pig vaccine were accidentally mixed with about 14 million kilograms of soybeans in the U.S. mid-west. ProdiGene, the Texas biotech company responsible for the mishap paid three million dollars in clean-up costs and fines. All of the soy was destroyed. The USDA tightened its rules after the huge public outcry, which even included the Biotechnology Industry Organization (BIO), the powerful U.S. biotech

industry lobby, asking its members to start growing biopharma crops in more isolated regions. Companies must now use designated equipment for planting and harvesting, provide better training for growers, and undergo at least five inspections a year. The new rules also require that biopharma maize be grown more than one km away from any other fields and planted at least 28 days before or after surrounding maize crops are sown. But the new rules are not strict enough, concluded the UCS-sponsored study , released in late December. The bottom line is: it is extraordinarily difficult

to prevent contamination. "Pollen can be carried to fields with food crops by the wind or insects, seeds lodged in the crevices of harvesting equipment could come loose while harvesting food, and plants can come up as volunteers in the middle of a food crop," said report editor Andow in a news release. The obvious solution is to grow biopharma crops in areas planted in non-food crops, like tobacco, says Rissler. But that might not happen. Maize is ideal for producing high volumes of proteins, as are soy and rice, and the three are among the most studied plants in the world.

"There is no scientific reason to shift biopharma into non-food crops," says Lisa Dry, a spokesperson for BIO. "The proteins being grown are well-known and present a low level of risk," Dry added in an interview. Even though BIO asked its members to grow biopharm maize in non-food producing zones after the ProdiGene incident, it is satisfied with current USDA regulations, which do not require such segregation. According to Dry, there are hundreds of products in the biotech pipeline, and biopharma products are likely to be commercially available within five years. Craig Winters of The Campaign to Label Genetically Engineered Foods , a U.S. NGO, predicts, "There will be drugs in breakfast cereals soon or later" because of large-scale planting of biopharma maize. But even growing them among non-food crops would be unsafe, he told IPS. Non-food biopharma crops could cross-pollinate with related wild plants and potentially transfer genes that produce the human proteins, he added. And pollen from maize has been documented

traveling dozens of kilometers . "The only safe way to grow these is in non-food crops inside greenhouses," argues Winters. Dry rejects that suggestion as unnecessary and too expensive. "Greenhouses would need to be several acres in size, which would greatly drive up the cost of production." But Winters warns that once cross-pollination transfers genes from biopharma crops into non-GE crops or other plants there will be no stopping it. "Those genes can't be recalled and it would be nearly impossible to clean up." More darkly, an escaped gene that impairs the world's ecosystem is not out the realm of possibility, he suggests. "Biopharma could be an important technology that brings the world cheap vaccines. But it has to be done right." While environmentalists, the biotech industry and regulators struggle over the potential benefits and risks of this new technology in the United States, there are no regulations and little discussion internationally . "The FAO (United Nations Food and Agriculture Organization) has not developed an official position specifically on GMOs (genetically modified organisms) containing biopharmaceuticals and industrial

chemicals," Andrea Sonnino of the FAO research and technology development service told IPS. In general terms the agency supports a science-based evaluation system that would objectively determine the benefits and risks of each individual GMO, including biopharma, Sonnino added in an email message. But organizations such as the UK-based Institute of Science in Society say international rules are needed quickly to prevent first-world corporations from using developing world countries as regulation-free testing and production grounds. In the meantime, bans on growing biopharma crops should be put in place by developing countries, the institute recommends. ©

Copyright 2004 IPS - Inter Press Service -- Living

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