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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.

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therapeutic genetic manipulations
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Genetic Enhancement
  • Fears are more pronounced for GD
    • Proposals to bar or limitGE
    • 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
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
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 enhancement19
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?