Ethics and the Biotech Industry

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Ethics and the Biotech Industry

  1. 1. Ethics and the Biotech Industry <ul><li>What is Bioethics? </li></ul><ul><li>Study of ethical principles and values that ought guide behavior and policy in biomedicine </li></ul>
  2. 2. What ethics is not <ul><li>Personal beliefs </li></ul><ul><li>What polls and surveys reveal </li></ul><ul><li>The law </li></ul><ul><li>Religious beliefs </li></ul>
  3. 3. What ethics is <ul><li>Justified principles and values </li></ul><ul><ul><li>Convincing argument </li></ul></ul><ul><ul><li>Pragmatic payoff </li></ul></ul><ul><li>Values that have appeal outside your own group or nation </li></ul><ul><li>Character and virtues that produce trust </li></ul>
  4. 4. Why ethics matters <ul><li>Ethics leads the law </li></ul><ul><li>Ethics sometimes is all there is </li></ul><ul><li>Ethics is what people care about when it comes to medicine and biotechnology! </li></ul><ul><ul><ul><li>Duty to protect patients and public health </li></ul></ul></ul><ul><ul><ul><li>Economic incentives are not enough and may well be mistrusted </li></ul></ul></ul><ul><ul><ul><li>Those who pursue health have a higher moral standard to meet </li></ul></ul></ul>
  5. 5. The 21st century will be the century of biology and the life sciences <ul><li>BUT WE ARE NOT READY TO RESPOND TO THE ETHICAL CONCERNS PEOPLE IN THE USA AND WORLDWIDE HAVE ABOUT THIS FACT </li></ul>
  6. 6. Ethical failure can kill biotech <ul><li>Fetal tissue research </li></ul><ul><li>Gene therapy </li></ul><ul><li>Stem cell research </li></ul><ul><li>GMO foods </li></ul><ul><li>Norplant </li></ul><ul><li>Research in the third world </li></ul>
  7. 7. Current Dangers: marketing <ul><li>Conflicts of Interest </li></ul><ul><li>Gifts </li></ul><ul><li>Intellectual Property </li></ul>
  8. 8. Current Dangers: Advertising <ul><li>DTC </li></ul><ul><li>Celebrities </li></ul><ul><li>Internet </li></ul><ul><li>Free trade and importing </li></ul><ul><li>Failure to Manage Ethics </li></ul>
  9. 9. Models for managing ethics and biotech <ul><li>Proactive product management </li></ul><ul><li>Hacking </li></ul><ul><li>Fire fighting (smoke jumpers) </li></ul><ul><li>Policy/Code formulation </li></ul><ul><li>Audit and educate </li></ul>
  10. 10. Managing ethics: case studies: proactive <ul><li>Pfizer and Viagra </li></ul><ul><ul><li>Recognition that a capability had medical value </li></ul></ul><ul><ul><li>Fear of entering a controversial market </li></ul></ul><ul><ul><li>Concern about unknown risk </li></ul></ul>
  11. 11. Ethical challenges of Viagra <ul><li>What is the disease </li></ul><ul><li>Just a quality of life issue </li></ul><ul><li>What about adverse events/deaths </li></ul><ul><li>What about misuse </li></ul><ul><ul><li>sexual crime, teenagers, illicit sex, sexually transmitted diseases, nursing homes </li></ul></ul><ul><li>How to get the drug </li></ul><ul><li>Advertising </li></ul>
  12. 12. Managing ethics: Hacker model <ul><li>Genomics collaborative </li></ul><ul><ul><li>Needs to obtain cells and tissues for biobanking </li></ul></ul><ul><ul><li>Payment to pathologists and surgeons </li></ul></ul><ul><ul><li>Consent for subjects </li></ul></ul><ul><ul><li>Property rights and ownership </li></ul></ul>
  13. 13. Managing ethics: fire fighting <ul><li>Framingham Genomics </li></ul><ul><li>NHLBI, BU, Harvard, private investors </li></ul><ul><li>Link data in Framingham study to genetic makeup of study subjects </li></ul><ul><li>Community uncertainty and study concerns about altruism </li></ul>
  14. 14. Managing Ethics: Policies and Codes <ul><li>Dupont and GMO </li></ul><ul><ul><li>Fix legacy of Monsanto </li></ul></ul><ul><ul><li>Deal with worldwide distrust of GMO </li></ul></ul><ul><ul><li>Problems are not just safety! </li></ul></ul><ul><ul><ul><li>Engineering nature </li></ul></ul></ul><ul><ul><ul><li>Fears of genetics </li></ul></ul></ul><ul><ul><ul><li>Losing biodiversity and culturally significant plants </li></ul></ul></ul><ul><ul><ul><li>Pollution </li></ul></ul></ul><ul><ul><ul><li>Informed consent about what people eat </li></ul></ul></ul><ul><ul><ul><li>Preserving ways of life </li></ul></ul></ul>
  15. 15. Managing ethics: auditing/educating <ul><li>Monitoring Dupont Biotech Code </li></ul><ul><li>Gene therapy </li></ul><ul><li>AstraZeneca </li></ul>
  16. 16. Is ethics going away anytime soon? <ul><li>Stem cell research </li></ul><ul><li>Transgenic animals </li></ul><ul><li>Cloning for medicines and food </li></ul><ul><li>Artificial organs </li></ul><ul><li>Germ line manipulation </li></ul><ul><li>Brain revolution </li></ul><ul><li>diagnosis </li></ul><ul><li>treatments </li></ul><ul><li>enhancement </li></ul><ul><li>Anti-aging </li></ul>
  17. 17. What must investors, CEOs, Boards and auditors do? <ul><li>Due Diligence </li></ul><ul><li>Understand bioethics </li></ul><ul><li>Prepare clients to cope </li></ul><ul><li>Enter public policy debates over ethics </li></ul>

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