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Ethics and the Biotech Industry. What is Bioethics? Study of ethical principles and values that ought guide behavior and policy in biomedicine. What ethics is not. Personal beliefs What polls and surveys reveal The law Religious beliefs. What ethics is. Justified principles and values

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Presentation Transcript
ethics and the biotech industry
Ethics and the Biotech Industry
  • What is Bioethics?
  • Study of ethical principles and values that ought guide behavior and policy in biomedicine
what ethics is not
What ethics is not
  • Personal beliefs
  • What polls and surveys reveal
  • The law
  • Religious beliefs
what ethics is
What ethics is
  • Justified principles and values
    • Convincing argument
    • Pragmatic payoff
  • Values that have appeal outside your own group or nation
  • Character and virtues that produce trust
why ethics matters
Why ethics matters
  • Ethics leads the law
  • Ethics sometimes is all there is
  • Ethics is what people care about when it comes to medicine and biotechnology!
      • Duty to protect patients and public health
      • Economic incentives are not enough and may well be mistrusted
      • Those who pursue health have a higher moral standard to meet
the 21st century will be the century of biology and the life sciences
The 21st century will be the century of biology and the life sciences


ethical failure can kill biotech
Ethical failure can kill biotech
  • Fetal tissue research
  • Gene therapy
  • Stem cell research
  • GMO foods
  • Norplant
  • Research in the third world
current dangers marketing
Current Dangers: marketing
  • Conflicts of Interest
  • Gifts
  • Intellectual Property
current dangers advertising
Current Dangers: Advertising
  • DTC
  • Celebrities
  • Internet
  • Free trade and importing
  • Failure to Manage Ethics
models for managing ethics and biotech
Models for managing ethics and biotech
  • Proactive product management
  • Hacking
  • Fire fighting (smoke jumpers)
  • Policy/Code formulation
  • Audit and educate
managing ethics case studies proactive
Managing ethics: case studies: proactive
  • Pfizer and Viagra
    • Recognition that a capability had medical value
    • Fear of entering a controversial market
    • Concern about unknown risk
ethical challenges of viagra
Ethical challenges of Viagra
  • What is the disease
  • Just a quality of life issue
  • What about adverse events/deaths
  • What about misuse

sexual crime, teenagers, illicit sex, sexually transmitted diseases, nursing homes

  • How to get the drug
  • Advertising
managing ethics hacker model
Managing ethics: Hacker model
  • Genomics collaborative
    • Needs to obtain cells and tissues for biobanking
    • Payment to pathologists and surgeons
    • Consent for subjects
    • Property rights and ownership
managing ethics fire fighting
Managing ethics: fire fighting
  • Framingham Genomics
  • NHLBI, BU, Harvard, private investors
  • Link data in Framingham study to genetic makeup of study subjects
  • Community uncertainty and study concerns about altruism
managing ethics policies and codes
Managing Ethics: Policies and Codes
  • Dupont and GMO
    • Fix legacy of Monsanto
    • Deal with worldwide distrust of GMO
    • Problems are not just safety!
      • Engineering nature
      • Fears of genetics
      • Losing biodiversity and culturally significant plants
      • Pollution
      • Informed consent about what people eat
      • Preserving ways of life
managing ethics auditing educating
Managing ethics: auditing/educating
  • Monitoring Dupont Biotech Code
  • Gene therapy
  • AstraZeneca
is ethics going away anytime soon
Stem cell research

Transgenic animals

Cloning for medicines and food

Artificial organs

Germ line manipulation

Brain revolution





Is ethics going away anytime soon?
what must investors ceos boards and auditors do
What must investors, CEOs, Boards and auditors do?
  • Due Diligence
  • Understand bioethics
  • Prepare clients to cope
  • Enter public policy debates over ethics