Genetic Engineering

1. Genetic Engineering

2. 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.

3. 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

4. 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.

5. 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.

6. 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

7. 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.

8. 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

9. 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?

10. 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

11. 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.

12. Current debate • Bar germ-line engineering? • Bar or limit enhancement of “normal” traits (either somatic or germ-line) • like intelligence, athleticism, beauty…..

13. 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??

14. 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

15. 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

16. 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”)

17. 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

18. 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?

19. 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?