PLANT-MADE PHARMACEUTICALS (PMPs) & PLANT-MADE INDUSTRIAL PRODUCTS (PMIPs): Oregon State University Outreach in Biotechnology Program by Erin McGregor, Intern Steve Strauss, PhD, Program Director, [email protected] Kirstin Carroll, PhD, Program Coordinator, [email protected] 541 737 6578 | Department of Forest Science - OSU, Richardson Hall, Corvallis, OR 97331-5752 http://wwwdata.forestry.oregonstate.edu/orb/ August 12, 2005 Summary of PMP/PMIP crops Plant-made pharmaceuticals (PMPs) and industrial products (PMIPs) are proteins produced by genetically engineered plants. This technique would allow for the production of important medical and industrial compounds without the drawbacks of current methods. PMPs and PMIPs could be less expensive to produce, more capable of producing proteins similar to human cells, and less likely to contain pathogens. On the other hand, PMP/PMIP crops do pose risks of contamination of the environment or food supply, possibly exposing humans and animals to compounds which could be harmful to their health without their knowledge. However, there are no universal risks or benefits that apply to all PMP/PMIP crops; each crop posses a unique set of pros and cons which must be assessed individually. PMP and PMIP crops are currently regulated by the USDA and FDA, who include the state in decisions about risks associated with these crops. Examples of the potential value of PMP/PMIP crops: ¾ New fibers and plastics could improve the healing process for surgical patients or radically change industrial textile properties. ¾ Biodegradable plastics and biofuels could create more sustainable products and reduce reliance on fossil fuels. ¾ Industrial enzymes could reduce the pollution created by paper and textile production. ¾ Biopharmaceuticals could be more easily and safely produced and more affordable for patients. ¾ Humanitarian efforts could be aided by more stable vaccines able to reach developing areas or by vaccines which could be given with a piece of fruit instead of a needle. ¾ Oregon farmers could benefit from value-added crops. ¾ Oregon researchers could benefit from grants and new research opportunities. Examples of the potential risks posed by PMP/PMIP crops: ¾ The transgenic crop could inadvertently enter the food supply, exposing consumers to potentially toxic compounds. ¾ Environmental contamination could occur, including the transfer of genes to wild plants or animals consuming the transgenic crop. ¾ The agricultural and food production industries could be held financially liable for problems related to food supply or environment contamination by recalls, lawsuits, or public perception issues. Summary of SB 570 Oregon SB 570 (Oregon Genetically Engineered Pharmaceutical and Industrial Crop Act), written by the Oregon chapter of Physicians for Social Responsibility, passed the Oregon Senate but did not reach a vote in the House before the end of the 2005 session. If passed, the bill would have placed a four-year moratorium on PMPs or PMIPs grown outdoors or using a food/feed crop in Oregon. These crops would have been banned for research purposes, as well as future commercial purposes. The bill would not have restricted GE crops producing chemicals they produce naturally, GE crops producing chemicals generally recognized as safe by the FDA, or non-food/feed biopharm crops grown inside in contained, controlled facilities. Although the bill would have allowed the production of “a greater or lesser quantity of a chemical or enzyme that naturally occurs in the plant,” such as plant-based enzymes, many such compounds undergo slight modification during genetic engineering to increase their production or performance, and thus could have also been banned due to vague wording of the bill. Box A (below) gives examples of specific products – vaccines, pharmaceuticals, and medical and industrial compounds – which could have been banned in Oregon by SB 570. BOX A: Examples of specific products that have been developed by researchers using transgenic plants but which could have been banned from any research in food crops and/or field cultivation in Oregon by SB 570: Vaccines and Antibodies: Vaccines for type I diabetes, cholera, E. coli, Norwalk virus, Hepatitis B, dental caries, malaria, influenza, cancer,2 hepatitis B, HIV.3 Tumor-associated marker antigen, secretory immunoglobin for treatment of dental caries, full-length IgG1, treatment of non-Hodgkin’s Lymphoma.2, 4 Vaccines against hepatitis B and Norwalk virus have already passed one stage of clinical trials.1 Biopharmaceuticals: Therapies for hepatitis B and C, liver cirrhosis, liver disease, cystic fibrosis, hemorrhage, hypertension, provitamin-A deficiency, amino acid deficiency.2 Two of the most expensive drugs: glucocerebrosidase and granulocyte-macrophage colony-stimulating factor, used to treat Gaucher’s disease and Neutropenia, respectively.2 Trypsin inhibitor for transplantation surgery, wound repair, and blood substitute.2 Other Medical Compounds: Proteins lactoferrin, lysozyme, and β-casein to fortify infant formula and other foods to prevent intestinal conditions, particularly child death to diarrhea.5, 7, 8 The human growth hormone somatotrophin, used to treat hypopituitary dwarfism in children, and potentially Turner syndrome, chronic renal failure, and HIV wasting syndrome.7 Collagens, used in the cosmetics and food industries, as well as for the production of medical and surgical supplies.5, 9 Elastin, present in ligaments and arterial walls and one of the strongest known natural fibers, could be used to prevent post-surgical adhesions and scars or as a transducer, superabsorbent, or biodegradable plastic.5, 9 Industrial Compounds: Biodegradable plastics using poly(3-hydroxyalkanoates) or poly(3-hydroxybutyrate), offering alternatives to petroleum-based polymers at time of decreasing petroleum reserves and increasing environmental concerns.5, 9 Crops with specific traits that are optimized for biofuels and bioenergy – such as optimized production of bio-based lubricants and esterified fatty acids – making the production of biofuels a more efficient process, a key step in creating a sustainable alternative to petroleum.11 Spider silk, which is stronger than and one-tenth the weight of high tensile steel, has a tensile strength comparable to that of the synthetic superfiber Kevlar, and can stretch to more than twice its length before breaking. Because of these phenomenal qualities, spider silk could be useful for a wide variety of industrial and medical purposes, including organ transplants.6, 9 Industrial enzymes, such as laccase which breaks down lignin and could be used in paper and textile production or water treatment plants instead of the current toxic processes.10 CITATIONS: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Transgenic Tobacco Plants Producing Human Interleukin-18. (2004). A. A. Turchinovich, et al. Doklady Biochemistry and Biophysics, 395: 104-107. Transgenic plants as factories for biopharmaceuticals. (November, 2000). G. Giddings, G. Allison, D. Brooks, & A. Carter. Nature Biotechnology, 18: 1151-1155. Antigens produced in plants by infection with chimeric plant viruses immunize against rabies virus and HIV-1. (May 27, 1997). V. Yusibov, et al. Proceedings of the National Academy of Sciences of the United States of America, 94 (11): 5784-5788. Secretory IgA Antibodies from Plants. (July, 2004). Wycoff, K.L. Current Pharmaceutical Design, 11 (19): 2429-2437. Transgenic plants as protein factories. (October, 2001). G. Giddings. Current Opinion in Biotechnology, 12(5):450-4. Production of spider silk proteins in tobacco and potato. (June, 2001). J. Scheller, KH. Gührs, F. Grosse, & U. Conrad. Nature Biotechnology, 19: 573-577. Biotech company planting genetically engineered rice in N.C. (July 16, 2005). David Rice. Winston-Salem Journal. Calif. company's 'pharmaceutical rice' plan sows controversy. (July 25, 2005). L. Morello. Greenwire. Plant-based material, protein and biodegradable plastic. (April, 2005). J. Scheller & U. Conrad. Current Opinion in Biotechnology, 8(2):188-196. Criteria for high-level expression of a fungal laccase gene in transgenic maize. E. E. Hood, et al. Plant Biotechnology Journal (2003). pp. 129–140. Crop biotechnology provides an opportunity to develop a sustainable future. (July, 2005). J.S. McLaren. Trends in Biotechnology, 23(7): 339-342. Other sources used: Altor BioScience to make therapeutic antibodies in transgenic lettuce. (July 21, 2005). Altro BioScience website: http://www.altorbioscience.com/ Biotechnology Industry Organization (BIO): http://www.bio.org/foodag/. Colorado State University, Transgenic Crops: http://www.colostate.edu/programs/lifesciences/transgeniccrops/hotbiopharm.html. Production of hepatitis B surface antigen in transgenic plants for oral immunization. (November, 2000). L.J. Richter, Y. Thanavala, C.J. Arntzen, & H.S. Mason. Nature Biotechnology, 18: 1167-1171. Scientists work to save tobacco farms. (July 21, 2005). A.R. Paley. Washington Post.
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