Download Genetic modification of humans

Chapter 20
Ethical issues of genomics
The ethical and social implications of
the genomics revolution
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Contents I
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Introduction
Ethics Law and Social Implications (ELSI)
Information in genome
Potential misuse of genomic information
Safeguards
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Contents II
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Genetic testing
Genomic sampling
Genetic counseling
Genetic modification of humans
Genetic modification of plants and animals
The role of scientists in public policy
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Introduction
 Major scientific
advances raise ethical
and social concerns
 Normally, scientists do
not initiate discussions
 e.g., Nuclear energy
 Exception: recombinantDNA technology
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Genomics and ELSI
 Genomics: first major research program to
allocate budget to ethical, legal, and social
implications (ELSI)
 Watson proposed 3–5% of HGP budget for
ELSI
 ELSI programs at NIHGRI and DOE
 Criticism: stifling criticism by buying critics
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
NIH ELSI mandate I
 To examine the issues surrounding the completion
of the human DNA sequence and the study of
human genetic variation
 To examine issues raised by the integration of
genetic technologies and information into health
care and public health activities
 To examine issues raised by the integration of
knowledge about genomics and gene–environment
interactions into nonclinical settings
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
NIH ELSI mandate II
 To explore ways in which new genetic knowledge
may interact with a variety of philosophical,
theological, and ethical perspectives
 To explore how socioeconomic factors and
concepts of race and ethnicity influence the use
and interpretation of genetic information, the
utilization of genetic services, and the
development of policy
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
ELSI programs
 Research into how
applications of
genomics are perceived
and received
 Basis for genetic
nondiscrimination laws
 Training of judges in
genetics and genomics
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Major issues raised by genomics
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Privacy of information
Privacy of biological samples
Genetic testing
Genetic modification
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Information in genome
 Genetic information as privacy issue
 Individual’s genome provides information on
the following:
 Disease susceptibility
 Longevity
 Behavioral traits
 How genes contribute to complex traits is still
unknown
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Utility of genomic information
 Information of potential use to
the following entities:
 Insurance companies
 Risk assessment
 Employers
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 Medical insurance premiums
 Behavior
 Government
 Military
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Discrimination based on genotype
 Insurance companies
 Refuse coverage
 Employers
 Hire and fire based on genetic makeup
 Government
 Genomic profile of criminal behavior
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Other misuses of genomic information
 Limiting access to financial resources
 e.g., mortgages
 Limiting access to education
 e.g., child with familial hypercholesterolemia
 Should the child be denied admission to
college?
 Should the child be given financial aid?
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Genetic discrimination
 Woman diagnosed as
deficient in a-aantitrypsin
 Predisposes to lung
diseases
 No symptoms
 Dismissed from job
because could require
expensive medication
 Successfully sued
employer
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Is genomic information different
from other medical information?
 Debate: Is genomic information different from
other medical information?
 Is it similar to cholesterol levels or blood
pressure?
 Decisions already based on health and genetic
information
 Pilots required to have 20/20 vision
 What differences are permissible to judge
individual on?
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
How genomic information differs
from other medical information
 Provides information about disease
susceptibilities
 “Future diary”
 Information resides in DNA molecules
themselves
 Argument for special safeguards
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Right to privacy
 Importance of individual freedom in U.S. laws
 “Right to be left alone”
 Strengthen existing laws
 Protection of medical confidentiality
 Informed consent
 Regulation of medical records
 Comprehensive genetic privacy laws
 Individual has control over personal DNA
samples and information extracted from them
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Genetic rights
 Right to determine whether and when one’s
DNA samples are collected, stored, or
analyzed
 Right to determine who has access to one’s
DNA samples
 Right to access one’s own genetic information
 Right to determine who has access to one’s
genetic information
 Right to information for informed decision
making
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Legal safeguards
 Genetic nondiscrimination laws
 Passed in more than 40 states
 Need laws about release of samples that
contain DNA
 Tissue or blood samples contain equivalent of
medical records
 Potential problems
 Linking of DNA and tissue to medical records
 Informed consent
 Ownership
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Genomic-sampling issues
 Tissue and DNA banks proliferating
 Gold mines of information
 Companies formed to collect DNA samples
 Example: deCODE Genetics
 Ethical issues
 Informed consent
 Profiting from information from specific
populations
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
deCODE Genetics
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Gene patenting
 Reasons for patenting include protection of
investment to develop product
 In return for teaching others how to make
invention
 Bayh–Dole Act: encouraged patenting from
publicly funded research
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Problems with patenting genes
 EST patenting
 Lack of functional information
 Utility
 “Patenting life”
 Public investment in genome projects
 Bermuda rules for immediate access
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
European Parliament directive on
patenting
 Human body, its parts, or sequence of its genes
cannot constitute patentable inventions
 An element isolated from human body, including
the sequence of a gene, may constitute a
patentable invention
 The industrial application of a gene sequence must
be disclosed in the patent application
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Genetic testing
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Can identify alleles that predispose for disease
Link between genetic testing and procreation
Limits of information
Problem: when there is no cure for a particular
disease
 Example: Huntington’s disease
 Issue of testing children
 For late-onset disease when no cure exists
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Huntington’s disease
 Autosomal-dominant neurological disorder
 Woody Guthrie died of it
 Age of onset varies
 Genetic basis known
 Triplet repeats
 More repeats: earlier onset
 No treatment or cure
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Genetic testing in the workplace
 Major railroad decided
to perform DNA tests on
employees
 Wanted to identify
susceptibility to carpal
tunnel syndrome
 Equal Employment
Opportunity
Commission filed suit to
block action
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Reasons for not having genetic tests
 Currently, tests exist for several diseases
 The number of people choosing to undergo
these tests is far fewer than companies or
physicians predicted
 Reasons:
 Fear of discrimination
 Concern over impact on families
 Lack of effective treatments
 Preference for uncertainty
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Who will pay for genetic testing?
 Genetic tests for many diseases likely to be
expensive
 e.g., whole-genome sequence for individual
 Willingness to pay for tests to resolve
uncertainty?
 Who will pay? Insurance companies?
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Genetic counseling
 Enabling patients to
make informed
decisions
 Problems once the
decision is made to
undergo tests
 Changes in selfperception
 Difficulty in adjusting
to low-risk status
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Targeted-therapy issues
 Pharmacogenomics promises therapy tailored
to individual’s genome
 More specific, fewer side effects
 Problem: smaller customer base
 Will pharmaceutical companies invest in
therapies for a smaller number of patients?
 Who will pay for targeted therapies?
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Genetic determinism
 Fate written in genes?
 Goes to heart of ideas of personal
responsibility
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Criminal behavior
“My genes made me do it”
Problem of “scientific evidence”
Very little currently known about relationship
of genes to criminal behavior
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Genetic modification of humans
 Eugenics movement
 Weed out “bad genes”
 Types of potential modification
 Disease or malformation related
 Cosmetic
 Behavioral
 Somatic vs. germ line modifications
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Cloning of humans
 Difficulty of cloning
humans
 Abnormalities in
animals
 Reasons for cloning
 Immortality
 Eugenics
 Organ donor
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Genetic modification of farm animals
 Transgenics and clones
 Scientists “playing
God”?
 Monoculture in animals
 Issues of suffering
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Genetic modification of crop plants
 Is the transfer of genes
into plants
fundamentally different
from breeding?
 Benefits of GMOs
 Improved agricultural
production
 Reduced herbicide use
 Fewer toxic pesticides
 Stress-resistant plants
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Possible risks of GMOs
 Spread of genes into
wild species
 Allergies
 Frankenfoods
 Balancing benefits and
risks
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Scientists and public policy
 Identifying potential risks
 Recombinant DNA
 Individual testimony
 Advisory committees
 Professional organizations
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Positive lessons from genomics
 Similarity of all humans 99.9%
 No genetic basis for race
 Homology of genes among all creatures
 Strong evidence for evolution
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Summary I
 Ethics, law, and social implications (ELSI)
 Information in genome
 Potential uses
 Potential misuses of genomic information
 Safeguards
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458
Summary II



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Genetic testing
Genomic sampling
Gene patenting
Genetic counseling
Genetic modification of humans
Genetic modification of plants and animals
The role of scientists in public policy
© 2005 Prentice Hall Inc. / A Pearson Education Company / Upper Saddle River, New Jersey 07458