Genetic Engineering - University of Missouri School of Law


14 déc. 2012 (il y a 9 années et 1 mois)

378 vue(s)

Genetic Engineering

Therapeutic Genetic

Drugs: bacteria engineered to produce
proteins needed by humans

Organs: Animals engineered to produce
tissue or organs that won’t be rejected by

Somatic genetic therapy
inserting “good”
DNA into humans to cure genetic disease.

line genetic therapy
“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

get informed consent of patients


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

safe & effective (FDA)

experimental human subjects protection(IRB;
malpractice law, esp. informed consent)

later use: informed consent?; Prod. & malp.

Genetic Engineering on the

Two kinds

genetic therapy

patient gets “good genes”

e.g., add genes to lung bronchi for CF

but they are
not transmissible

to kids


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.

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

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

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.)


are extra research safeguards

Civil liability=malpractice law

did it violate standard of care to do it?

Was informed consent obtained?


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

Currently too risky to do on humans

most embryos are likely to die or have
serious maladies

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

line engineering?

Bar or limit

of “normal”
traits (either somatic or germ

like intelligence, athleticism, beauty…..

line eng’g


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”

Debate surrounds use of gene therapy to
enhance traits like intelligence,
athleticism, beauty…..

Already being debated about some non
genetic enhancements

enhancing drugs in sports

human growth hormone for “short” kids

Human Growth Hormone

Wonderful as treatment for severe

What if other families want it for “short”

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

Fears are more pronounced for GD

Proposals to bar or limit


Critics fear both somatic and germ
line GE

Especially germ
line bc potentially eternal

What is the fear??

Vague uneasiness with

“no good will come of this”

Genetic aristocracy=
exacerbate inequality

and make permanent

rich convert wealth into eternal traits


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?