Genetic Engineering
Therapeutic Genetic
Manipulations
Drugs: bacteria engineered to produce
proteins needed by humans
Organs: Animals engineered to produce
tissue or organs that won’t be rejected by
humans.
Somatic genetic therapy
--
inserting “good”
DNA into humans to cure genetic disease.
Germ
-
line genetic therapy
--
inserting
“good” DNA into sperm, egg, embryo.
Bacteria engineered to
produce proteins
Many already, including insulin
Legal/ethical issues=not unique
test first for safety & efficacy (FDA)
human subjects protection during tests
(IRBs)
get informed consent of patients
thereafter
any need to inform patients thereafter???
product liability & malpractice laws apply if
unreasonably dangerous
Organs and tissue
Animals engineered to be “organ farms”
New animal ethics issues
Familiar legal issues raised by use on
humans
safe & effective (FDA)
experimental human subjects protection(IRB;
malpractice law, esp. informed consent)
later use: informed consent?; Prod. & malp.
Genetic Engineering on the
Patient
Two kinds
Somatic
genetic therapy
patient gets “good genes”
e.g., add genes to lung bronchi for CF
but they are
not transmissible
to kids
Germ
-
line
genetic therapy
inserting “good” DNA into sperm, egg, or
very early (undifferentiated) embryo
if successfully inserted into DNA ribbon, then
will be transmissible to kids.
Somatic
genetic therapy
Identify diseases that have genetic causes
protein miscues (too few; too many, wrong
ones; wrong timing, etc.)
Identify the responsible genes and make
copies of “good” genes in vitro.
Insert genes into humans
hoping the genes will activate & make
proteins
does not “fix” the underlying “bad” genes
Somatic techniques
Remove blood cells, add genes and return
to patient
Deliver directly to site
bronchial tubes (CF)
muscles (muscular dystrophy)
cancer tumors (suicide genes)
Future: invent “carriers” to take genes to
target cells.
Somatic risks
Viruses used to deliver genes into cells
must be neutered
Augmented cells = limited life span
so will need repeat treatment periodically
New genes can insert themselves
randomly into the DNA
of the cell’s
chromosomes.
Ex: disrupt tumor suppression genes??
“In situ” may not go to chosen tissue
Somatic: legal issues
Patient died in Philadelphia last year
Federal granting authorities impose
“human subjects” safeguards (IRBs, etc.)
Debate:
are extra research safeguards
needed?
Civil liability=malpractice law
did it violate standard of care to do it?
Was informed consent obtained?
Germ
-
line
genetic therapy
inserting “good” DNA into sperm, egg, or
very early (undifferentiated) embryo
won’t remove bad DNA
if successfully inserted into DNA ribbon,
then will be transmissible to future
generations.
Currently too risky to do on humans
most embryos are likely to die or have
serious maladies
Germ
-
line legal issues
Existing law raises same issues as somatic
1. Human subjects protections if federally
funded or regulated.
2. Malpractice remedies
BUT in informed consent cases, wrongful
birth/wrongful life restrictions may arise here.
If child would not have been conceived or carried
to term if parents had been told all the risks.
Not a problem in cases alleging carelessly
performed genetic therapy.
Current debate
Bar
germ
-
line engineering?
Bar or limit
enhancement
of “normal”
traits (either somatic or germ
-
line)
like intelligence, athleticism, beauty…..
Germ
-
line eng’g
Recall
AMA reco’s moratorium
Some experts would prohibit
Why so worrisome?
Too risky to child
for “parents” to consent?
Renegade MDs won’t even get that?
Risks are eternal & uncertain
Immoral tinkering
with human heritage??
Enhancement of “normal”
traits
Debate surrounds use of gene therapy to
enhance traits like intelligence,
athleticism, beauty…..
Already being debated about some non
-
genetic enhancements
performance
-
enhancing drugs in sports
human growth hormone for “short” kids
Human Growth Hormone
Wonderful as treatment for severe
disease
What if other families want it for “short”
kid?
MD’s debate whether it’s part of their mission
(not “treatment”?)
Insurers debate coverage
Ethicists worry about impact on norms of
“normalcy” and unequal access.
But relatively low profile debate before
potential for
genetic
enhancement
Genetic Enhancement
Fears are more pronounced for GD
Proposals to bar or limit
GE
Critics fear both somatic and germ
-
line GE
Especially germ
-
line bc potentially eternal
What is the fear??
Vague uneasiness with
hubris?
“no good will come of this”
Genetic aristocracy=
exacerbate inequality
and make permanent
rich convert wealth into eternal traits
Social
coercion
to use (“be more productive”)
Balancing Risks v. Benefits
Are the risks materially worse than for
enhancements already permitted?
Worse Coercion?
Baldness cures, liposuction, implants
like performance
-
enhancing drugs? For attorneys?
Worse Inequality?
Naturally gifted?
Wealthy=access to private schools, SAT prep
classes; health care; Prozac
More Unnatural?
Vaccination, organ transplants, Prozac, caffeine
Benefits of Genetic Enh’t?
End baldness? Shaving legs?
End obesity?
Better resistance to environmental toxins?
Improved memory, concentration, etc
MDs and pilots?
Fewer industrial accidents? Auto accidents?
Genetic Enhancement
For now, the risks preclude human use.
Eventually, they may be reduced
Question then:
leave to individual
choice or restrict/bar?
Narrow or broad restrictions?
“clean” LSAT exam?
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