Genetic Engineering - University of Missouri School of Law

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?