Con 2

1
Con 2

• Concerned scientists and physicians
• Kelly Oliver
• Laura Ordway
• Tim Raymond

Mr. Thorstein Johansson
2
Goals

• Ethical principles of consent and confidentiality
• Science of gene therapy
• Proposed promises stated by deCODE and conflicts
  associated with monopoly

3
deCODE

• Private company in Iceland
• Purpose create biobanks
• Access to two types of data

4
Types of Data

• Link participant data to genealogical data
• Health Sector Database
• Includes 270,000 individuals
• 12 year license
• All medical data in Iceland inserted into database

5
Ethical Issues

• Consent
• Act on Biobanks Researchers are allowed to use
  the clinical medical samples for research as long
  as a health care professional or health
  institution provided general information on the
  topic, and the patient did not object.
• The Data Protection Commission is authorized to
  give access to information contained in clinical
  records for the purpose of scientific research.

6
Ethical Issues contd

• Confidentiality
• The current health databases are currently
  attracting attention and are therefore a concern
  for misuse of such information (Chadwick, 1999).
• When researching human genetic databases,
  complete de-linkage between personal
  identification and medical, genetic, and other
  data is not possible since it is vital to be able
  to follow-up that person over time (Cardinal,
  2003).

7
United States

• The Americans with Disabilities (ADA)
• Prohibits discrimination against a qualified
  individual with a disability (Miller, 2002).
• Prohibits discrimination against workers based on
  their genetic makeup (Miller, 2002).
• HIPAA
• Prohibits using any health status-related factor,
  including genetic information, as a basis for
  denying or limiting eligibility of a particular
  person.

8
Difficulties of Gene Therapy
9
Obstacles

• 1. Target the right cells
• Location in the body
• Gain entrance
• 2. Activate
• Find cell nucleus
• Transcription, translation
• Functional protein
• 3. Maintenance
• Gene stays viable in target cells
• Becomes part of host genome
• Somatic vs. Germline

10
Obstacles contd

• 4. Avoid side effects
• Toxicity of added gene solution
• Auto immune response

11
Case Study 1

• Stanford-gene therapy trial
• Drs. treat hemophiliac
• Modified adenovirus
• Vector
• Transfer good genes
• Integrates into genome less than retrovirus
• If integrates in genes
• Cell may mutate
• Can cause cancer
• Children with Severe Combined Immunodeficiency
  Disease (SCID) developed leukemia
• Often seen with retroviruses
• Must integrate into DNA to work
• Current goal
• Develop vectors that work and arent integrated
  into genome
• Director Mark Kay
• I dont think we need to modify anything at this
  point. But this is a risk well have to address
  before the vector is in widespread use.

12
Case Study 2

• Jesse Gelsinger
• Liver disorder patient
• Disease under control
• Volunteered to help others
• Injected with vector
• 24 hours later in coma
• Died 2 days after
• Cause of death unknown
• Project shut down by FDA
• Participants uninformed
• Monkeys previously died
• Early human volunteers w/ serious side effects
• Neglected information from similar liver
  experiment
• NIH receives gt 600 reports serious adverse
  events relating to similar clinical trials

13

• Looking beyond our capabilities
• Jumping the gun
• Not safe for humans
• Science is new and dynamic
• Poorly planned/executed experiments
• Billions of dollars
• Avoidable deaths
• Gene testing
• Broad deductions
• Unaffordable to poor
• Lack of available medical options
• Provokes anxiety
• Discrimination

14
What will the future look like?

• Paradigmatic shift in the study of medicine
• If we can cure everything through genes
• Will all Drs. become geneticists?
• If gene therapy does not work
• Study of medicine
• Decrease in physiological knowledge
• If we can stop whats happening in the body, who
  cares why it is happening?
• Shortage of physicians capable of performing
• Surgery
• Minimally invasive techniques
• Diagnosis and correct medical treatment separate
  of genes.
• Will it ever be affordable?
• Current techniques and medications more
  advanced, successful everyday
• Put into these
• Little ethical controversy
• Ownership or Utilitarianism
• A modern eugenics?
• Medicine and action is placed completely into the
  hands of those that wield it
• Powerlessness

15
Impossible promises

• The new jobs offered by the information cannot
  practically exist
• Greely and King quote
• Research by people at computers
• Promised net financial and medical benefit
• More of a cruel joke than a reality- Greely
  King
• Moneys received by government will not cover all
  expenses
• Supposed free medications

16

• Personal information in hands of for-profit
  organization
• DeCode can choose who accesses database
• Data is controlled by 3 person legislature
• One person has license
• Commission cannot access data which may harm
  financial interest of licensee
• Scientists access dependent upon licensee
• People do not own their genes-the company does

17
Mr. Thornstein Johansson

• Exemplifies unethical realities
• A review of case
• Risk of disease revealed to his company
• Liability fired from job
• He should be compensated for this loss

18
The 12 year monopoly

• Terrifying example of how science can become so
  carried away by dreams of glory and profits that
  it abandons good research practice and runs
  roughshod over the rights of individuals.
• Jorunn Eyjifjord-head of molecular
  genetics-Icelandic Cancer Society
• Iceland people may be guinea pig population of
  the future
• This process may be echoed in other countries
• Prediction as the project gains more attention,
  more physicians will opt to protect their
  patients, and not the DeCode monopoly

19
Literature Cited

• Cardinal, Genevieve, Deschenes, Mylene Survey of
  National Approaches to the Development of
  Population Biobanks. Canadian Biotechnology
  Advisory Committee. Ottawa, ON 2003
• Chadwick, Ruth The Icelandic Database-Do Modern
  Times Need Modern Sagas? 319 BMJ 441-444 1999
• DeCODE Genetics, Unique Resources
  http//www.decode.com (date accessed November
  28, 2005)
• Lander, Eric Opening Address, International DNA
  sampling 2002.
• Miller, Paul Analyzing Genetic Discrimination in
  the Workplace, Human Genome News. Vol. 12 NOS.
  1-9 February 2002.
• Winickoff, E. David Context and content of
  Icelands Biobanks Act, Journal of Biolaw and
  Business 42 2000.
• Check, Erika Harmful potential of viral vectors
  fuels doubts over gene therapy, Nature 423,
  573-574 (5 June 2003).
• Casey, Denise K. Genes, Dreams, and Reality-The
  promises and risks of the New Genetics. American
  Judiciary Society. Nov-Dec 1999 Vol 83(3).
• Gene Therapy, February 2, 2000.
  http//www.pbs.org/newshour/bb/health/jan-june00/g
  ene_therapy_2-2.html.
• Lyall, Sarah. A Country Unveils Its Gene Pool
  and Debate Flares. NEW YORK TIMES 16 Feb.
• 1999 cited 2 Nov. 2005. Available from
  lthttp//www.nytimes.com/library/national/science/0
  21699sci-iceland-genes.htmlgt
• Greely, Henry T. and Mary Clairre King. Letter
  to the Government of Iceland. 1998 cited 2 Nov.
  
• 2005. Available from lthttp//www.mannvernd.is/en
  glish/articles/greely__king-e.htmlgt
• Slatkin, Montgomery. Letter to Einar Arnason.
  28 Sept. 1998 cited 2 Nov. 2005. Available
  from
• lthttp//www.mannvernd.is/english/articles/28.10.19
  98_montgomery_slatkin.htmlgt
• Helland, Dag E. Ethical Concerns Over Licensing
  Health Data. 27 Nov. 1998 cited 2 Nov. 2005.
• Available from lthttp//www.mannvernd.is/english/a
  rticles/27.11.1998_nordic_committee.htmlgt
• Arnason, Einar. A Biased Database Hurts People
  3 Dec. 1998 cited 2 Nov. 2005. Available from
• lthttp//mannvernd.is/english/articles/10.12.1998_b
  iased_database_hurts_einar_arnason.html