Running head: VENTRIA BIOSCIENCE AND PLANT-MADE MEDICINES

Ventria Bioscience and the Controversy over Plant-made Medicines GB580 Corporate Social Responsibility Professor Charles Needham Dione Scott August 30, 2011

VENTRIA BIOSCIENCE AND PLANT-MADE MEDICINES Introduction Many people suffer from numerous diseases, infections and many other symptoms that cause frustration and death. Finding ways to relieve the pain has been the aim of many individuals and companies for a long time. Parents worry when their children become sick and they cannot seem to relieve them of the pain. Illness such as diarrhea has been one problem that has affected children and adults alike for many years. The World Health Organization estimated that the worlds children suffer 4 billion episodes of diarrhea per year. Nearly 2 million of these children die annually from the disease, mainly through dehydration and malnutrition. Ventria Bioscience a biotechnology company set out to produce pharmaceutical proteins in the seeds of genetically modified rice. This medicine was designed to reduce the severity of childhood diarrhea especially in the developing world. This venture proved to be epic if only it could be accepted by the general public, regulatory bodies, the California Rice Commission and the numerous farmers and importers of rice around the world (Lawrence & Weber, 2011, p. 490 493). To relieve the pain that many children face is a noble venture that shows how innovative

Ventria is, but to what expense? Will the rice farmers suffer, the environment or citizens. Ventria believes firmly that they can provide their plant-made medicine and not harm the general population and the environment but how certain are they that they can accomplish such a task. Finding ways to improve the methods used to plant the rice can lead to them being accepted by the public and bring their product to the general public. Ventria and the Plant-made Medicine Ventria was founded in 1993 by Dr. Raymond Rodriquez, a molecular biologist. He and his graduate students embarked on an ambitious research program aimed at improving the

VENTRIA BIOSCIENCE AND PLANT-MADE MEDICINES productivity of rice. He went on to develop techniques to express medically useful proteins in rice plants that could be extracted and purified. With the funding of Dr. William Rutter, Rodrguez opened a lab in Sacramento, California. The lab researched on roughly 15 medical and industrial proteins. Ventria set out to use genetic engineering to phytomanufacture protein pharmaceuticals and other commercially valuable compounds in plants. In 2002 the board of Ventria hired the capable Scott Deeter as the president and CEO. He and his team examined the many ideas that the company had and recommended that the company selected the projects that

had the highest probability of succeeding commercially. The team decided that the best project to tackle was that of the proteins lactoferrin and lysozyme. These two compounds were naturally found in breast milk and from research done proved to be the factor that caused breast fed babies to experience less diarrhea episodes than those who were not. Ventria believed that adding these two compounds to oral rehydration solutions will improve the effectiveness of this medicine for the treatment of diarrhea and gastrointestinal illnesses (Lawrence & Weber, 2011, p. 490, 493). Plant-made medicine possessed many benefits and risks. The benefits were the fact that plant grown medicine would cost less to produce than conventional, mammalian all culture technology. Using mammalian or microbial cells to make therapeutic proteins was also dangerous as animal tissues can transmit viruses. Another benefit was that rice and other agricultural crops could be stored at room temperature for months to years allowing processing facilities to operate year round and supply demand. Plant grown medicine could provide ways for medical proteins to be delivered orally without extensive purification. This was enough reason for Ventria to be excited about their proteins. There also existed some drawbacks. The fact that most plant-made medicines were grown in crops also used for food posed the problem of commingling and contamination of human and animal food supplies. There was also the

VENTRIA BIOSCIENCE AND PLANT-MADE MEDICINES problem of cross breeding with wild plants or food crops causing hybrids that can be harmful to the environment and uncontrollable. Ethical issues of genetically altering food could also stem serious criticism from the public (Lawrence & Weber, 2011, p. 493, 494). The Problem Ventria Faces To get the plan of the ground Ventria had to go through both state and federal regulatory

approval. At the federal level Ventria had to be approved by three bodies. The first was the Food and Drug Administration (FDA). This body was responsible for the safety and effectiveness of food and medicines. Ventria stated that Lactiva (lactoferrin) and Lysomin (lysozyme) were generally recognized as safe (GRAS) food additives thus requiring a lower threshold for approval. Even though this was accepted the FDA did not clear Ventrias product as they had zero tolerance for pharmaceutical crop products in any food intended for animal or humans. The second body was the Environmental Protection Agency that was responsible for the environmental safety of food crops genetically engineered to contain pesticides or other substances potentially harmful to the environment. They focused pesticides which the Ventria product did not contain therefore they were approved by this body. The third body was the U.S. Department of Agricultures (USDA) Animal and Plant Health Inspection Service looked at genetically modified crops being tested in fields. Ventria encountered problems with 2 of these bodies as the regulatory system was complex, overlapping and outdated. At the state level was where Ventria found its toughest fight. California was home to a major rice industry. They were the second leading producers of small and medium grain rice in the US accounting for 2 percent of the worlds rice and 14 percent of the international rice trade and generated more than $500 million in sales annually. Therefore this state was greatly invested

VENTRIA BIOSCIENCE AND PLANT-MADE MEDICINES in this industry and ensured that it was protected. The California state government established the California Rice Commission (CRC) they promoted the sale of rice, educated and instructed the wholesale and retail trade with respect to the proper handling and selling of rice and conduct scientific research. The commission appointed an advisory board that had the right to review varieties of rice having characteristics of commercial impact except for rice planted for research on 50 or fewer acres. This body could not legally prohibit the production of rice but they had a major influence on the California Secretary of Agriculture who could. Deeter planned to expand the acreage of rice planted to 120 acres in 2003 therefore placing them under the radar of the CRC. During the advisory board meeting they discussed the protocols and proposals that Ventria proposed. The board had many concerns. Such as the commercial threats in exports. Their concerns were based on the fact that the Japanese Rice Retailers Association was strongly against any genetically altered rice and would stop imports from California. This would have a grave impact as Japan was an important client. The board voted and 6 of 11 approved Ventrias protocols. Ventria requested and emergency status that would give the California Secretary of Agriculture 10 days to approve or disapprove the protocols. Within this time several farmers and groups voiced their concern about the impact it

would have. They focused on the environmental impacts such as the possibilities of commingling and cross pollination that can occur even over far distances through high winds, insects, birds and natural disasters such as flooding and tornadoes. The cross breeding with existing weed species could also create problems such as super weeds that can spread like wild fire. They also looked at the economic implications as it related to farmers. It could affect the exports which contributed to the economy of the state. It could also put organic farmers in jeopardy. As they have spent years to build a market and the possibility of commingling could ruin it. They also

VENTRIA BIOSCIENCE AND PLANT-MADE MEDICINES raised issues regarding the well-being of the society. They stated that rice grown for human consumption could become contaminated and cause infections, allergies and autoimmune disorders. The main proteins used can boost pathogens including the bacteria that causes gonorrhea and meningitis and can lead to ulcers and stomach cancers. Therefore while relieving

the pain of diarrhea in children they could end up harming many individuals. Deeter and his team offered numerous concessions to address all the concerns. They have suggested planting their rice far from other farmers, use dedicated equipment, increase sanitization, have third party inspections and have detailed logs of all activities. This however did not appease those concerned and Ventrias faith was still left to chance (Lawrence & Weber, 2011, p. 494 500). Recommendations The concerns of the farmers and the various groups were all important and to move them onto the side of Ventria the company needs to make major changes to their protocols and ideas. Ventria could look at finding other ways to produce the medicine or try to tweak it to reduce the effect it will have on humans in case of an unpreventable contamination. If this is not possible the company should try and find other areas within California that they could plant the rice. These areas should be more than 100 miles from any rice farms or other farms. They could also venture into different states that are not so dedicated to rice or rice export. This will reduce the pressure on organic rice farmers and regular small and medium grain rice farmers. The site of choice could be a self-contained and constantly monitored to ensure that birds and insect cannot get in or out to cause any cross pollination. This site should have proper protection from floods and tornadoes. This idea would be costly but the benefits and approval would pay off. Regular inspections and a constant log by individuals especially employed to monitor the farm should be implemented. The site should have dedicated equipment that is sanitized and cleaned on a

VENTRIA BIOSCIENCE AND PLANT-MADE MEDICINES

regular basis within enclosed areas of the site. Packing and transporting should be well organized and safe. There should never be any interactions of rice or other crops within the transportation period. Proper warnings and labels should be advertised around the area of the selected sites. The concept of plant-made medicine is extraordinary and can make a big difference in the pharmaceutical field and lead to many lives being saved and provide the global community with affordable health products. With such a possibility Ventria should be come creative thinkers and find strategies to make it work.

VENTRIA BIOSCIENCE AND PLANT-MADE MEDICINES References

Lawrence, A. T. (2011). Ventria bioscience and the controversy over the plant-made medicines. In Lawrence, A. T. Weber, J., Business and Society: Stakeholders, Ethics, Public Policy (pp.490-500). New York: McGraw-Hill.