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Bioethics 2003 Retreat Summary

The 2003 Bioethics Retreat was held on January 10, 2003, at Iowa State University. More than 45 faculty and Extension personnel were in attendence to discuss the use of the precautionary principle as a guide to sound science and policy. As a case study, participants discussed with stakeholders how the precautionary principle can be applied to scientific research and legal regulations on pharmaceutical crops.

The following links provide an overview of the retreat and the results of a day of discussion about the future of biotechnology:

• Summary of retreat from Bioethics in Brief newsletter
  
• Retreat schedule and recommended readings
  
• Speaker Bios
  
• PowerPoint® presentations from speakers
  
• Working group recommendations

Speaker Presentations

Carl Cranor
Dr. Cranor reviewed the idea of precaution using examples, like protecting Michelangelo's Last Judgment in the Sistine Chapel, where precaution comes naturally. He then emphasized the need to inventory and evaluate the status quo regarding the things we care about (such as the environment) from a scientific perspective, and explained the characteristics of a "more anticipatory science."

"What Could Precautionary Science Be? Research for Early Warnings and a Better Future"
PowerPoint® format or HTML format

In his second presentation, Dr. Cranor reviewed the current system of legal regulations for potentially toxic substances and provided an overview of what he would consider a precautionary legal agenda.

"Some Legal Implications of the Precautionary Principle: Improving Information-Generation and Legal Protections"
PowerPoint® format or HTML format

Doug Getter
Mr. Getter discussed the business opportunities presented by new biopharming technology. He emphasized the need for policies that will allow people to achieve the benefits of biopharming while minimizing the risks.

Laura Krause
Ms. Krause discussed her experience farming in the Mt. Vernon area. She described the consequences to her farm when the open-pollinated corn variety that she inherited from the farm's previous owners tested positive for the presence of a transgenic event, raising the issue of how benefits and harms from transgenic technologies should be distributed.

GianCarlo Moschini
Dr. Moschini analyzed the precautionary principle from an economist's perspective. He found that the precautionary principle displays many reasonable features, but is vague and ambiguous and can be misused. Dr. Moschini then contrasted the precautionary principle with a learn-then-act principle, and found that the precautionary principle is "neither necessary nor sufficient for a rational risk management policy."

"Decisions under Risk and the Precautionary Principle: An Economist's Perspective"
Summary of lecture (PDF format only)

Carolyn Raffensperger
Ms. Raffensperger introduced the history and evolution of the precautionary principle and explained the common elements that characterize the precautionary principle even in different contexts. She raised "precautionary questions for pharming" and discussed twelve lessons learned about the precautionary principle.

"Implementing the Precautionary Principle: Thoughtful strategies for protecting public health and the environment"
PowerPoint® format or HTML format

Kan Wang
Dr. Wang explained how vaccines work and discussed the benefits of oral vaccines. She explained the advantages of using plants, corn in particular, as bioreactors. She also discussed issues of concern in developing such research, including regulatory and environmental considerations, and suggested ways to address these issues.

"Corn as a production and delivery system for oral vaccines"
PowerPoint® format or HTML format

Working Group Recommendations

Group One
The first group considered several courses of action regarding the implementation of pharmaceutical crops:

1. One possible action is to reject the technology or to not commercialize it.
2. Isolation or containment was another possible action to take. The group recommended either geographic isolation or planting seeds in a different season to avoid contamination with non-pharmaceutical crops.
3. They also suggested the possibility of developing pharmaceutical crops in plants that are not open-pollinated, selecting one that will avoid the spread of pollen.
4. If corn is used (as one of Iowa's primary crops) for pharmaceutical plants, a way should be found to keep pharmaceuticals out of the plant's pollen.
5. One last suggestion was to make the pharmaceutical genes express only in certain part(s) of the plant.
6. The group suggested that items three and four on this list were possibly the best suggestions of these five.

They also discussed the likelihood of harm, and found there were definitely economic risks, but other potential risks included ecological, health, and social risks. Overall, there is a high uncertainty about the use and development of pharmaceutical crops, which may be irreversible.

Group Two
The second group members said they were uneasy with using the precautionary principle in regards to pharmaceutical crops because the crops are already being developed. They developed eleven actions to consider for future development of pharmaceutical crops:

1. Better understanding of environmental concerns; they were concerned that we may lack qualified people for this due to higher education specialization.
2. Develop societal goals; the question was raised concerning how to involve citizens in this process.
3. Protein specificity; i.e., a barrier or correct environment for pharmaceutical crops. They recognized that this might be difficult to achieve.
4. Hold public forums to gather opinions on problems and benefits to society.
5. Product characterization; there were several elements of this discussed, including increasing knowledge (the more you know, the better); develop testing methods to keep up with the rate of development; including any indirect effects (e.g., secondary metabolism).
6. Assess the implications of proteins; how significant is the risk?
7. Expose misrepresentation of farmers' views of economic prospects of pharmaceutical crops.
8. Develop an inventory and monitoring system for pharmaceutical crops.
9. Develop protocols for dealing with unintended consequences.
10. Focus money on causes, not effects; e.g., make a vaccine versus figuring out why pigs have a disease. Investigate the alternatives.
11. Those who develop pharmaceutical crops should be held liable for any negative effects.

In conclusion, the group said it is unrealistic to assume that we can control these technologies in the end.

1. FDA approval of the drug (the process of extraction, purity of product) is the issue to be followed, but the FDA doesn't deal with plants.
2. Choose the crop carefully; maybe corn is not the crop to be chosen for pharmaceutical plant development.
3. There should be an open discussion of the consequences, including a broad cross-section of the population.
4. There has not been enough consideration of risk assessment and risk management approaches.

1. Assessing legal liability to risks; this group considered legal liability to be a "huge" area to consider for this issue, with substantial consequences for all.
2. Assess the benefits of drugs and pharmaceutical crops.
3. Before release of pharmaceutical crops, questions should be answered through research and about research.
4. The regulatory process needs to recognize the social impacts and economic impacts of pharmaceutical crops.
5. It must be decided where to grow these crops; the group said it may not be Iowa.
6. Decide on consequences of value-added production, including financial, risks, environmental, social, etc.
7. What effects on the aquatic system (cumulative and interactive effects) of multiple drugs introduced.

1. Understand the proteins involved in pharmaceutical crops.
2. Assess and understand the environmental impact of pharmaceutical crops, including inventory and monitoring.
3. Assess and understand the society-wide impact via public involvement. Include an accurate representation of all views. It is important for institutions and politics to represent the public appropriately.
4. Develop a response plan for unintended consequences, including liability issues.
5. Encourage funding of multiple approaches to a problem. Don't look for a silver bullet to fix all the problems.
6. Cross-disciplinary thinking is important for understanding the impact of technologies.