Genetic Engineering

							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
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?