Genetic Engineering - University of Missouri School of Law

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14 Δεκ 2012 (πριν από 4 χρόνια και 4 μήνες)

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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?