Transcript NOTES: Bioethics

Biotechnology with a Conscience - Bioethics
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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
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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
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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
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Assuming stem cells can only be
obtained from embryos (those that are
discarded during in-vitro fertilization):
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Should public money fund this research?
Should such activities be legal?
Public Policy Case # 2
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A new variety of genetically modified
corn is being made available that resists
pests without the use of pesticide.
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Should this GMO be approved for use by
the USDA?
Should it be labeled as GMO?
Company Policy Case# 1
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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
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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
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A close relative has had a stroke. At the
hospital, the doctor provides you with two
treatment options
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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
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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
1. Define the term “bioethics.”
2. Give an example of an event that might lead a lab employee to be
faced with an ethical issue.
3. 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?