Biotechnology with a Conscience - Bioethics How do we learn what is right and wrong behavior? As new situations arise in your life, how do you decide what is acceptable behavior and what is unacceptable? How do you decide what is fair and just? Moral Standards Being able to distinguish between right and wrong and to make decisions based on that knowledge is considered “having good morals.” The study of moral standards and how they affect conduct is called ethics. New technologies generate ethical questions that cannot be answered using scientific methods. Products are regulated by FDA, USDA, and EPA.

Strategy for Values Clarification Identify and understand the problem or issue. Learn as much as possible about the issue. List all possible solutions to the issue. Identify the pros and cons of adopting each solution. Examine the consequences of adopting one solution (or position) as opposed to another. Consider legal, financial, medical, personal, social, and environmental aspects. Based on the pros and cons for each solution, rank all solutions from best to worst. Decide if the problem is important enough to take a position. If it is, decide what your position is and be prepared to describe and defend it.

Public Policy Case #1 Assuming stem cells can only be obtained from embryos (those that are discarded during in-vitro fertilization): Should public money fund this research? Should such activities be legal?

Public Policy Case # 2 A new variety of genetically modified corn is being made available that resists pests without the use of pesticide. Should this GMO be approved for use by the USDA? Should it be labeled as GMO?

Company Policy Case# 1 Your company has developed a drug that can prevent transmission of HIV from an infected mother to a nursing baby in 990 out of 1000 cases. However, in the other 10 cases, a severe reaction occurs – possibly causing death of mother and/or baby. Your company wants to conduct phase III clinical trials in Africa where the incidence of HIV infection is rising fast. You are on a committee that is charged with this decision.

Company Policy Case # 2 Company A has invested $300 M in a drug that can treat hyperparathyroidism (a disease leading to low calcium and bone loss). The drug is in phase III trials and results are dramatic. However, one of the 1000 patients treated had a drug interaction with a commonly used medicine. Your pharmacologist predicts that this may happen in about 5% of the patients. A second generation molecule (which addresses this issue) is about 2 years behind (cost of development = $200 MM + lost revenue = $100 MM). How would you proceed?

Personal and Public Policy Case #1 A close relative has had a stroke. At the hospital, the doctor provides you with two treatment options Streptokinase (chance of survival 6%, cost $1,000) Activase (chance of survival 7%, cost $20,000) Which treatment would you opt for (if you were paying for it)? Should medicare reimburse use of Activase? Should an insurance company pay for activase?

Personal Case # 2 You are working on developing a process for a new drug. Your boss is eager to get “good results” showing 2 fold increase in productivity. You are likely to get a promotion based on these results. The actual results are less than desirable. You could doctor the results. The process would then be scaled up and the management would likely blame the scale-up for the process failure. What would you do?

1.6 Review Questions Define the term “bioethics.” Give an example of an event that might lead a lab employee to be faced with an ethical issue. Describe how the Strategy for Values Clarification can be used to solve a problem such as the use of embryonic stem cells for basic research.

Questions and Comments?